510(k) K061280

V-2200 INFANT INCUBATOR by Neoforce Group, Inc. — Product Code FMZ

K061280 is an FDA 510(k) premarket notification submitted by Neoforce Group, Inc. for the device "V-2200 INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on June 27, 2006. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Neoforce Group, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2006
Date Received
May 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type