510(k) K020219
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2002
- Date Received
- January 22, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Infant Radiant
- Device Class
- Class II
- Regulation Number
- 880.5130
- Review Panel
- HO
- Submission Type