510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K813198Substantially Equivalent

Respirator Monitor

Florida Medical Equipment Repair, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813198 is the FDA 510(k) clearance record for RESPIRATOR MONITOR, a class II device, cleared for Florida Medical Equipment Repair, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 2 510(k) clearances for Florida Medical Equipment Repair, Inc., from to . As of , FDA records show no recalls naming K813198.

Clearance record

Decision date
Received
(25 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Florida Medical Equipment Repair, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260