510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063609Substantially Equivalent

River- 1 Electrocardiograph (ECG) Recorder and Transmitter

SHL TeleMedicine International, Somerset MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063609 is the FDA 510(k) clearance record for RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER, a class II device, cleared for Shl Telemedicine International , Ltd. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 5 510(k) clearances for Shl Telemedicine International , Ltd., from to . As of , FDA records show no recalls naming K063609.

Clearance record

Decision date
Received
(282 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Shl Telemedicine International , Ltd. 291 Hillside Ave., Somerset MA
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