510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901846Substantially Equivalent

Ohmeda - Logic 07A Transport Ventilator

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

K901846 is the FDA 510(k) clearance record for OHMEDA - LOGIC 07A TRANSPORT VENTILATOR, a class II device, cleared for Ohmeda Medical on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K901846.

Clearance record

Decision date
Received
(106 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Ohmeda Medical 9065 Guilford Rd., Columbia MD
Third party review
No

Clearances, product code BTL

Trailing 12 months

FDA records hold no clearances under product code BTL in the trailing twelve months.

FDA records show no clearances under product code BTL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260