DeviceClearance

TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE— 510(k) K854013

Substantially Equivalent

Medrand, Inc.

FDA 510(k) clearance K854013 for TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE, Substantially Equivalent on 1986-02-28. Applicant: Medrand, Inc.. Device class: 2.

Clearance details

Applicant
Medrand, 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
Cincinnati, OH, US
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