510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971808Substantially Equivalent

Space Chamber for Model Number and Accessories

Monarch Medical, Blaine WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971808 is the FDA 510(k) clearance record for SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES, a class II device, cleared for Monarch Medical on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Monarch Medical. As of , FDA records show no recalls naming K971808.

Clearance record

Decision date
Received
(134 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Monarch Medical 4550 Birch Bay/Lynden Rd., Blaine WA
510(k) summary
Statement
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