510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973985Substantially Equivalent

As/3 Anaesthesia Delivery Unit (As/3 Adu)

Datex-Engstrom, Inc., Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973985 is the FDA 510(k) clearance record for AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU), a class II device, cleared for Datex-Engstrom, Inc. on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 10 510(k) clearances for Datex-Engstrom, Inc., from to . As of , FDA records show 8 recalls naming K973985.

Clearance record

Decision date
Received
(375 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex-Engstrom, Inc. 2 Highwood Dr., Tewksbury MA
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