510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K111116Substantially Equivalent

Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000

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

K111116 is the FDA 510(k) clearance record for ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000, a class II device, cleared for Datex-Ohmeda on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 4 recalls naming K111116.

Clearance record

Decision date
Received
(141 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex-Ohmeda P.O. Box 7550, Madison WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260