510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053599Substantially Equivalent

Spacelabs Medical Multigas Analyzer Module 91518 and Accessories

GE Healthcare, Issaquah WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053599 is the FDA 510(k) clearance record for SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES, a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 2 recalls naming K053599.

Clearance record

Decision date
Received
(117 days to decision)
Product code
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Regulation
21 CFR 868.1700
Device class
Class II
Review panel
Anesthesiology
Applicant
Spacelabs Medical, Inc. 5150 220th Ave. SE, Issaquah WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBR

Trailing 12 months

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

FDA records show no clearances under product code CBR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBR, 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