510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854927Substantially Equivalent

Icor Calaric Measurement Unit (Cmu)

Icor AB, Bromma, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854927 is the FDA 510(k) clearance record for ICOR CALARIC MEASUREMENT UNIT (CMU), a class II device, cleared for Icor AB on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list 16 510(k) clearances for Icor AB, from to . As of , FDA records show no recalls naming K854927.

Clearance record

Decision date
Received
(107 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Icor AB Ulvsundavagen 178 B, Bromma, SE
Third party review
No

Clearances, product code BZL

Trailing 12 months

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

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