REUSABLE FINGER SENSOR 3444
FDA 510(k) clearance K974697 · decided 1998-03-11
Clearance details
- K-number
- K974697
- Device name
- REUSABLE FINGER SENSOR 3444
- Applicant
- Bci Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-16
- Decision date
- 1998-03-11
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DQH
- Device class
- 2
- Regulation number
- 870.2310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.