510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882817Substantially Equivalent

Lung Diffusion Gas Mixture

Swisco, Inc., Lake Charles LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882817 is the FDA 510(k) clearance record for LUNG DIFFUSION GAS MIXTURE, a class II device, cleared for Swisco, Inc. on under FDA product code BYK (Tent, Oxygen, Electrically Powered). FDA records list 3 510(k) clearances for Swisco, Inc., from to . As of , FDA records show no recalls naming K882817.

Clearance record

Decision date
Received
(38 days to decision)
Product code
BYK Tent, Oxygen, Electrically Powered
Regulation
21 CFR 868.5710
Device class
Class II
Review panel
Anesthesiology
Applicant
Swisco, Inc. P.O. Box 1563, Lake Charles LA
Third party review
No

Clearances, product code BYK

Trailing 12 months

FDA records hold no clearances under product code BYK in the trailing twelve months.

FDA records show no clearances under product code BYK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260