510(k) K882084
K882084 is an FDA 510(k) premarket notification submitted by Pediatric Diagnostic Service for the device "GENESIS TM FETAL SYSTEM". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Pediatric Diagnostic Service has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1989
- Date Received
- May 18, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Monitoring, Perinatal
- Device Class
- Class II
- Regulation Number
- 884.2740
- Review Panel
- OB
- Submission Type