DIGITAL MEDICINE ECG MONITOR AND RECORDER— 510(k) K880971
Substantially EquivalentDigital Medicine Systems
FDA 510(k) clearance K880971 for DIGITAL MEDICINE ECG MONITOR AND RECORDER, Substantially Equivalent on 1988-08-30. Applicant: Digital Medicine Systems. Device class: 2.
Clearance details
- Applicant
- Digital Medicine Systems
- 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
- Cambridge, MA, US
Recent devices under product code DXH
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