CUFF PACER
FDA 510(k) clearance K780703 · decided 1978-07-17
Clearance details
- K-number
- K780703
- Device name
- CUFF PACER
- Applicant
- Omp Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-25
- Decision date
- 1978-07-17
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- CBA
- Device class
- 2
- Regulation number
- 868.2025
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.