510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834460Substantially Equivalent

Model 1888 Alpha Cos/respiration Car

Spacelabs, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834460 is the FDA 510(k) clearance record for MODEL 1888 ALPHA COS/RESPIRATION CAR, a class II device, cleared for Spacelabs, Inc. on under FDA product code LLK (Legging, Compression, Non-Inflatable). FDA records list 46 510(k) clearances for Spacelabs, Inc., from to . As of , FDA records show no recalls naming K834460.

Clearance record

Decision date
Received
(56 days to decision)
Product code
LLK Legging, Compression, Non-Inflatable
Regulation
21 CFR 880.5780
Device class
Class II
Review panel
General Hospital
Applicant
Spacelabs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LLK

Trailing 12 months

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

FDA records show no clearances under product code LLK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLK, 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