510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K981047Substantially Equivalent

Fresh Air

Colorado Medtech, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981047 is the FDA 510(k) clearance record for FRESH AIR, a class II device, cleared for Colorado Medtech, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list 2 510(k) clearances for Colorado Medtech, Inc., from to . As of , FDA records show no recalls naming K981047.

Clearance record

Decision date
Received
(545 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Colorado Medtech, Inc. 6175 Longbow Dr., Boulder CO
510(k) summary
Statement
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260