510(k) K062052
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2006
- Date Received
- July 20, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Incubator, Neonatal Transport
- Device Class
- Class II
- Regulation Number
- 880.5410
- Review Panel
- HO
- Submission Type