510(k) K931346
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1993
- Date Received
- March 17, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal Transport
- Device Class
- Class II
- Regulation Number
- 880.5410
- Review Panel
- HO
- Submission Type