510(k) K801757
K801757 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MMI/GAELTEC CATHETER TIP PRESS. TRANSDU". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code FES (Recorder, External, Pressure, Amplifier & Transducer), a Class II device regulated under 21 CFR 876.1725. Medical Measurements, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1980
- Date Received
- July 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, External, Pressure, Amplifier & Transducer
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type