510(k) K821896

C-300 INFANT INCUBATOR by Narco Scientific — Product Code FMZ

K821896 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "C-300 INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on Jul 28, 1982. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Narco Scientific has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 28, 1982
Date Received
Jun 28, 1982
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
510(k)

Source: FDA 510(k) database entry for K821896. Report a data issue: hello@regdatalab.com.