Clearance Summary
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. received FDA 510(k) clearance under submission number K873150, sponsored by Pediatric Diagnostic Service. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1988-03-11.
- Submission: K873150
- Applicant / Sponsor: Pediatric Diagnostic Service
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 1988-03-11
Classification & Regulation
This clearance is catalogued under FDA product code HFM and 21 CFR 884.2720, within the Obstetrics/Gynecology review panel as a Class II device.