510(k) K780035
K780035 is an FDA 510(k) premarket notification submitted by Metrix Teknika, Inc. for the device "MINIVISOR". The FDA issued a decision of Substantially Equivalent on March 6, 1978. The device falls under product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Metrix Teknika, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1978
- Date Received
- January 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Heart Rate, Fetal, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type