510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021605Substantially Equivalent

Medgem

Healthetech, Inc., Golden CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K021605 is the FDA 510(k) clearance record for MEDGEM, a class II device, cleared for Healthetech, Inc. on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list 2 510(k) clearances for Healthetech, Inc., from to . As of , FDA records show no recalls naming K021605.

Clearance record

Decision date
Received
(29 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Healthetech, Inc. 523 Park Pt. Dr., Golden CO
510(k) summary
Statement
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