510(k) K002503
K002503 is an FDA 510(k) premarket notification submitted by Analogic Corp. for the device "FETALGARD LITE". The FDA issued a decision of Substantially Equivalent on Nov 9, 2000. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Analogic Corp. has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 2000
- Date Received
- Aug 14, 2000
- 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
- 510(k)