510(k) K870783
K870783 is an FDA 510(k) premarket notification submitted by Fisher Imaging Corp. for the device "BPA CARDIOVASCULAR PRESSURE AMPLIFIER". The FDA issued a decision of Substantially Equivalent on Apr 27, 1987. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Fisher Imaging Corp. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 1987
- Date Received
- Feb 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Amplifier And Signal Conditioner, Transducer Signal
- Device Class
- Class II
- Regulation Number
- 870.2060
- Review Panel
- CV
- Submission Type
- 510(k)