510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933836Substantially Equivalent

Hbm Hemoglobinometer

Artel, Inc., Windham ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933836 is the FDA 510(k) clearance record for HBM HEMOGLOBINOMETER, a class II device, cleared for Artel, Inc. on under FDA product code GIG (Hemoglobinometer). FDA records list 3 510(k) clearances for Artel, Inc., from to . As of , FDA records show no recalls naming K933836.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GIG Hemoglobinometer
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Artel, Inc. 12 Depot St., Windham ME
510(k) summary
Summary
Third party review
No

Clearances, product code GIG

Trailing 12 months

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

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