510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K925580Substantially Equivalent

Ohmeda Tec 6 (Cfv) Continuous Flow Vaporizer, Nad

Ohmeda Anesthesia Systems Therapy Group, Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925580 is the FDA 510(k) clearance record for OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD, a class II device, cleared for Ohmeda Anesthesia Systems Therapy Group on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 2 510(k) clearances for Ohmeda Anesthesia Systems Therapy Group, from to . As of , FDA records show one recall naming K925580.

Clearance record

Decision date
Received
(210 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Ohmeda Anesthesia Systems Therapy Group P.O. Box 7550, Madison WI
510(k) summary
Statement
Third party review
No

Clearances, product code BSZ

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