510(k) K053399
K053399 is an FDA 510(k) premarket notification submitted by Draeger Medical Infant Care, Inc. for the device "VERSALET 7700 CARE CENTER". The FDA issued a decision of Substantially Equivalent on August 4, 2006. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Draeger Medical Infant Care, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2006
- Date Received
- December 6, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type