510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083630Substantially Equivalent

Clue Medical and Clue Medical Basic

Telovital GmbH Telemedizin, Alexandria VA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083630 is the FDA 510(k) clearance record for CLUE MEDICAL AND CLUE MEDICAL BASIC, a class II device, cleared for Telovital GmbH Telemedizin on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 2 510(k) clearances for Telovital GmbH Telemedizin, from to . As of , FDA records show no recalls naming K083630.

Clearance record

Decision date
Received
(136 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Telovital GmbH Telemedizin 901 King St., Suite 200, Alexandria VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260