510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801050Substantially Equivalent

Supra Scope

Warner-Lambert Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801050 is the FDA 510(k) clearance record for SUPRA SCOPE, a class I device, cleared for Warner-Lambert Co. on under FDA product code BZS (Stethoscope Head). FDA records list 50 510(k) clearances for Warner-Lambert Co., from to . As of , FDA records show no recalls naming K801050.

Clearance record

Decision date
Received
(9 days to decision)
Product code
BZS Stethoscope Head
Regulation
21 CFR 868.1930
Device class
Class I
Review panel
Anesthesiology
Applicant
Warner-Lambert Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BZS

Trailing 12 months

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

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