510(k) K884086

C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR by Air-Shields Vickers, Inc. — Product Code FMZ

K884086 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR". The FDA issued a decision of Substantially Equivalent on November 14, 1988. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Air-Shields Vickers, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
September 27, 1988
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