510(k) K123309
K123309 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "GIRAFFE AND PANDA WARMERS". The FDA issued a decision of Substantially Equivalent on February 5, 2013. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohmeda Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2013
- Date Received
- October 24, 2012
- 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