510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974349Substantially Equivalent

Ohmeda-Ohio Care Plus Incubator

GE Healthcare, Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974349 is the FDA 510(k) clearance record for OHMEDA-OHIO CARE PLUS INCUBATOR, a class II device, cleared for Ohmeda Medical 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 2 recalls naming K974349.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Ohmeda Medical 9065 Guilford Rd., Columbia MD
510(k) summary
Summary
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