510(k) K870857
K870857 is an FDA 510(k) premarket notification submitted by Applied Biometrics, Inc. for the device "ABCOM 1 CARDIAC OUTPUT MONITOR". The FDA issued a decision of Substantially Equivalent on November 16, 1987. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Applied Biometrics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1987
- Date Received
- March 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 870.2880
- Review Panel
- CV
- Submission Type