510(k) K121625
K121625 is an FDA 510(k) premarket notification submitted by Wipro GE Healthcare Private, Ltd. for the device "LULLABY TM WARMER". The FDA issued a decision of Substantially Equivalent on September 14, 2012. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Wipro GE Healthcare Private, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2012
- Date Received
- June 1, 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