510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K082539Substantially Equivalent

Masterscope, Masterscope ECG, Masterscope CT

Cardinal Health Germany 234 GmbH, Hoechberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082539 is the FDA 510(k) clearance record for MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT, a class II device, cleared for Cardinal Health Germany 234 GmbH on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list 2 510(k) clearances for Cardinal Health Germany 234 GmbH, from to . As of , FDA records show no recalls naming K082539.

Clearance record

Decision date
Received
(91 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Cardinal Health Germany 234 GmbH Leibnizstrasse 7, Hoechberg, DE
510(k) summary
Summary PDF
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