SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
FDA 510(k) clearance K021246 · decided 2002-05-13
Clearance details
- K-number
- K021246
- Device name
- SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
- Applicant
- Sensidyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-19
- Decision date
- 2002-05-13
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.