510(k) K873150
K873150 is an FDA 510(k) premarket notification submitted by Pediatric Diagnostic Service for the device "PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.". The FDA issued a decision of Substantially Equivalent on March 11, 1988. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Pediatric Diagnostic Service has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1988
- Date Received
- August 11, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Uterine Contraction, External (For Use In Clinic)
- Device Class
- Class II
- Regulation Number
- 884.2720
- Review Panel
- OB
- Submission Type