Apr

2007

Inc, Class II Pulse Biomedical

Company:Pulse Biomedical, Inc
Date of Enforcement Report:4/11/2007
Class:ll

PRODUCT
QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine, Recall # Z-0716-2007

REASON
No 510 (k) marketing clearance for the product.

CODE
Serial numbers: 4605AU0251E, 2306AU0600E-BT, 2306AU0601E-BT, 2406AU0610E-BT, and 2706AU0641E-BT.

RECALLING FIRM/MANUFACTURER
Pulse Biomedical, Inc., Norristown, PA, by telephone and letter dated March 5, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units

DISTRIBUTION
NY, NJ, Chile, Greece, and the Netherlands

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Inc, Class II Pulse Biomedical

Amy Sellers

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