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510(k) Premarket Notification - accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100813
    PULSE BIOMEDICAL, INC. 1305 CATFISH LANE: NORRISTOWN, PA 19403 Correspondent Contact: SALEEM HASAN: Regulation Number: 870.2340: Classification …

Pulse Biomedical Inc FDA Filings

    https://fda.report/Company/Pulse-Biomedical-Inc
    This page includes the latest FDA filings for Pulse Biomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo …

510(k) Premarket Notification - accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K972255
    PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM: Applicant: PULSE BIOMEDICAL, INC. 935 SOUTH TROOPER RD. …

2020 Device Approvals | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
    Medical Devices Cleared or Approved by FDA in 2020. Device Name. Category. Date. Vercise™ PC and Vercise Gevia™ Deep Brain Stimulation (DBS) …

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT …

    https://fda.report/PMN/K972255
    Device ID: K972255: 510k Number: K972255: Device Name: PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM: Classification: 510(k) …

13 - Food and Drug Administration

    https://www.accessdata.fda.gov/cdrh_docs/pdf10/K100813.pdf
    Pulse Biomedical Ombil RDIf RkS~r Bzhehn 4. 72474 r~m~nhtqak GERMANY Tel: +49-7414-Ai160IS Far .49-7434-fl 603 Special 510(k) -QRS CardTm'I S-T Segment Analysts …

Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.

Pulse Biomedical

    https://qrscard.com/about.html
    Pulse Biomedical, Inc. (PBI) is now a reseller of computer-based Cardiology Equipment (previously a FDA registered manufacturer) including Resting, Stress and Holter ECG …

510(k) Premarket Notification - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
    510 (k) Premarket Notification. FDA Home. Medical Devices. Databases. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as …

FDA-Approved Devices That Help Keep the Heart …

    https://www.fda.gov/consumers/consumer-updates/fda-approved-devices-help-keep-heart-beating
    Cardiovascular angioplasty devices: These are long, thin, flexible tubes that are threaded into a heart or other blood vessel to open narrowed or blocked areas. They are intended …



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