510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971030Substantially Equivalent

Mie Falcon, Datex Engstrom Flexima II

Medical and Industrial Equipment, Ex2 7na Exeter, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971030 is the FDA 510(k) clearance record for MIE FALCON, DATEX ENGSTROM FLEXIMA II, a class II device, cleared for Medical and Industrial Equipment on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list one 510(k) clearance for Medical and Industrial Equipment. As of , FDA records show no recalls naming K971030.

Clearance record

Decision date
Received
(237 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical and Industrial Equipment Falcon Rd. Sowton Industrial, Ex2 7na Exeter, GB
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