510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K863801Substantially Equivalent

Tmm Model 3000 Anesthesia Circuit Evaluator

Traverse Medical Monitors, Saline MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863801 is the FDA 510(k) clearance record for TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR, a class II device, cleared for Traverse Medical Monitors on under FDA product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)). FDA records list 2 510(k) clearances for Traverse Medical Monitors, from to . As of , FDA records show no recalls naming K863801.

Clearance record

Decision date
Received
(105 days to decision)
Product code
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Regulation
21 CFR 868.1620
Device class
Class II
Review panel
Anesthesiology
Applicant
Traverse Medical Monitors 6812 S. State Rd., Saline MI
Third party review
No

Clearances, product code CBS

Trailing 12 months

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

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