510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911647Substantially Equivalent

Ngm Gas Module

Datex Division Instrumentarium Corp., Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911647 is the FDA 510(k) clearance record for NGM GAS MODULE, a class II device, cleared for Datex Division Instrumentarium Corp. on under FDA product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K911647.

Clearance record

Decision date
Received
(157 days to decision)
Product code
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Regulation
21 CFR 868.1500
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex Division Instrumentarium Corp. 2 Highwood Dr., Tewksbury MA
Third party review
No

Clearances, product code CBQ

Trailing 12 months

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

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