CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)— 510(k) K942586
Substantially EquivalentTelescan Medical Systems
FDA 510(k) clearance K942586 for CARDIAC EVENT RECORDER (INSTANT MEMORY 2000), Substantially Equivalent on 1995-05-10. Applicant: Telescan Medical Systems. Device class: 2.
Clearance details
- Applicant
- Telescan Medical 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
- Auburn, CA, US
Recent devices under product code DXH
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