NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS— 510(k) K844391

Substantially Equivalent

Ams Medical, Inc.

FDA 510(k) clearance K844391 for NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS, Substantially Equivalent on 1985-01-07. Applicant: Ams Medical, Inc..

Clearance details

Applicant
Ams Medical, Inc.
Product code
Code DXH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
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