510(k) K910982
K910982 is an FDA 510(k) premarket notification submitted by M.D. Engineering, Inc. for the device "INNERVISION IRRIGATION PUMP". The FDA issued a decision of Substantially Equivalent on August 26, 1991. The device falls under product code HEI (Monitor, Heart-Valve Movement, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. M.D. Engineering, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1991
- Date Received
- March 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Heart-Valve Movement, Fetal, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type