RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER— 510(k) K954163
Substantially EquivalentCardiac Evaluation Center, Inc.
FDA 510(k) clearance K954163 for RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER, Substantially Equivalent on 1996-07-11. Applicant: Cardiac Evaluation Center, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiac Evaluation Center, 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
- Milwaukee, WI, US
Recent devices under product code DXH
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