CAPILLARY SAMPLE LINE
FDA 510(k) clearance K771516 · decided 1977-08-16
Clearance details
- K-number
- K771516
- Device name
- CAPILLARY SAMPLE LINE
- Applicant
- Mcgaw Respiratory Therapy
- Decision
- Substantially Equivalent
- Date received
- 1977-08-08
- Decision date
- 1977-08-16
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- CCI
- Device class
- 2
- Regulation number
- 868.1690
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CO2/02 MONITOR MULTINEX (K872024) | Datascope Corp. | 1988-03-31 |
Recalls involving this device
No recalls on record reference this clearance.