510(k) K883334
K883334 is an FDA 510(k) premarket notification submitted by Diagnosis Related Systems, Inc. for the device "BIODOP(TM)". The FDA issued a decision of Substantially Equivalent on December 15, 1988. The device falls under product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1988
- Date Received
- August 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type