510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863675Substantially Equivalent

Calibration Gas for Servo Gas Monitor 120

Siemens Elema AB, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863675 is the FDA 510(k) clearance record for CALIBRATION GAS FOR SERVO GAS MONITOR 120, a class I device, cleared for Siemens Elema AB on under FDA product code BXK (Gas, Calibration (Specified Concentration)). FDA records list 63 510(k) clearances for Siemens Elema AB, from to . As of , FDA records show no recalls naming K863675.

Clearance record

Decision date
Received
(45 days to decision)
Product code
BXK Gas, Calibration (Specified Concentration)
Regulation
21 CFR 868.6400
Device class
Class I
Review panel
Anesthesiology
Applicant
Siemens Elema AB 2360 N. Palmer Dr., Schaumburg IL
Third party review
No

Clearances, product code BXK

Trailing 12 months

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

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