510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K970844Substantially Equivalent

Atomisor

Medical Consulting Service, Inc., Altamonte Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970844 is the FDA 510(k) clearance record for ATOMISOR, a class II device, cleared for Medical Consulting Service, Inc. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Medical Consulting Service, Inc. As of , FDA records show no recalls naming K970844.

Clearance record

Decision date
Received
(251 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Consulting Service, Inc. 658 Douglas Ave.,Suite 1110, Altamonte Springs FL
510(k) summary
Summary
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