510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213553Substantially Equivalent

Giraffe Incubator Carestation CS1

GE Healthcare, Wauwatosa WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213553 is the FDA 510(k) clearance record for Giraffe Incubator Carestation CS1, a class II device, cleared for Datex Ohmeda, Inc. on under FDA product code FMZ (Incubator, Neonatal). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K213553.

Clearance record

Decision date
Received
(114 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Datex Ohmeda, Inc. 9900 Innovation Dr., Wauwatosa WI
510(k) summary
Summary PDF
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