510(k) K921062
K921062 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "GAELTEC MPR SERIES". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), 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
- July 30, 1992
- Date Received
- March 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Gastrointestinal Motility (Electrical)
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type