510(k) K780703
K780703 is an FDA 510(k) premarket notification submitted by Omp Laboratories, Inc. for the device "CUFF PACER". The FDA issued a decision of Substantially Equivalent on July 17, 1978. The device falls under product code CBA (Monitor, Air Embolism, Ultrasonic), a Class II device regulated under 21 CFR 868.2025. Omp Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1978
- Date Received
- April 25, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Air Embolism, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 868.2025
- Review Panel
- AN
- Submission Type