NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS— 510(k) K844391
Substantially EquivalentAms 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.. Device class: 2.
Clearance details
- Applicant
- Ams Medical, 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
- Minneapolis, MN, US
Recent devices under product code DXH
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