CARDIOSENTRY EVENT MONITOR, MODEL 8470-01— 510(k) K001634
Substantially EquivalentTz Medical, Inc.
FDA 510(k) clearance K001634 for CARDIOSENTRY EVENT MONITOR, MODEL 8470-01, Substantially Equivalent on 2000-12-21. Applicant: Tz Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Tz 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
- Lake Oswego, OR, US
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