510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860798Substantially Equivalent

Arf-1500 Continuous Ventilator

Medimex, Inc., West Hempstead NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860798 is the FDA 510(k) clearance record for ARF-1500 CONTINUOUS VENTILATOR, a class II device, cleared for Medimex, Inc. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 3 510(k) clearances for Medimex, Inc., from to . As of , FDA records show no recalls naming K860798.

Clearance record

Decision date
Received
(128 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Medimex, Inc. 300 Hempstead Tpke., West Hempstead NY
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260