510(k) K061856
K061856 is an FDA 510(k) premarket notification submitted by Atom Medical, Inc. for the device "V-2200 INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on September 28, 2006. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Atom Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2006
- Date Received
- June 30, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type