DeviceClearance

PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES— 510(k) K061977

Substantially Equivalent

Pinmed, Inc.

FDA 510(k) clearance K061977 for PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES, Substantially Equivalent on 2006-07-21. Applicant: Pinmed, Inc.. Device class: 2.

Clearance details

Applicant
Pinmed, Inc.
Product code
Code DXH
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pittsburg, PA, US
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