510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954962Substantially Equivalent

Spacelabs Medical Multigas Analyzer

Spacelabs, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954962 is the FDA 510(k) clearance record for SPACELABS MEDICAL MULTIGAS ANALYZER, a class II device, cleared for Spacelabs, Inc. on under FDA product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)). FDA records list 46 510(k) clearances for Spacelabs, Inc., from to . As of , FDA records show no recalls naming K954962.

Clearance record

Decision date
Received
(214 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, Inc. 15220 NE 40th St., Redmond WA
510(k) summary
Statement
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