510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011339Substantially Equivalent

Quest Exercise Stress System, Model Configuration 14

Spacelabs Burdick, Inc., South West Ranches FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011339 is the FDA 510(k) clearance record for QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14, a class II device, cleared for Spacelabs Burdick, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list one 510(k) clearance for Spacelabs Burdick, Inc. As of , FDA records show no recalls naming K011339.

Clearance record

Decision date
Received
(110 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Spacelabs Burdick, Inc. 20310 SW 48th St., South West Ranches FL
510(k) summary
Summary
Third party review
No

Clearances, product code DSI

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