510(k) K822656

C-200 INFANT INCUBATOR by Narco Scientific — Product Code FMZ

K822656 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "C-200 INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on Oct 18, 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
Oct 18, 1982
Date Received
Sep 3, 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 K822656. Report a data issue: hello@regdatalab.com.