510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855069Substantially Equivalent

Spirometer Ts-400 Slz 7547

Teledyne Avionics Div. of Teledyne, Charlottesville VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855069 is the FDA 510(k) clearance record for SPIROMETER TS-400 SLZ 7547, a class II device, cleared for Teledyne Avionics Div. of Teledyne on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list 13 510(k) clearances for Teledyne Avionics Div. of Teledyne, from to . As of , FDA records show no recalls naming K855069.

Clearance record

Decision date
Received
(43 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Teledyne Avionics Div. of Teledyne P.O. Box 6400 (Rt. 743), Charlottesville VA
Third party review
No

Clearances, product code BTY

Trailing 12 months
1 clearance under product code BTY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260