510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060811Substantially Equivalent

Omron Compressor Systems, Models Ne-C28,ne-C30

Omron Healthcare Co., Ltd., Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060811 is the FDA 510(k) clearance record for OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30, a class II device, cleared for Omron Healthcare, Inc. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K060811.

Clearance record

Decision date
Received
(62 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Omron Healthcare, Inc. 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260