510(k) K780487
K780487 is an FDA 510(k) premarket notification submitted by Sonicaid, Inc. for the device "FETAL MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code HFO (Recorder, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Sonicaid, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1978
- Date Received
- March 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type