510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913394Substantially Equivalent

Incubator 8000 Ic

Dragerwerk AG, Oakdale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913394 is the FDA 510(k) clearance record for INCUBATOR 8000 IC, a class II device, cleared for Dragerwerk AG on under FDA product code FMZ (Incubator, Neonatal). FDA records list 3 510(k) clearances for Dragerwerk AG, from to . As of , FDA records show no recalls naming K913394.

Clearance record

Decision date
Received
(115 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Dragerwerk AG C/O National Draeger, Inc., Oakdale PA
510(k) summary
Statement
Third party review
No

Clearances, product code FMZ

Trailing 12 months
2 clearances under product code FMZ in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FMZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260