510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062397Substantially Equivalent

Sentinel

GE Healthcare, Hasbrouck Heights NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062397 is the FDA 510(k) clearance record for SENTINEL, a class II device, cleared for Del Mar Reynolds Medical, Ltd. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K062397.

Clearance record

Decision date
Received
(162 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Del Mar Reynolds Medical, Ltd. 377 Rte. 17s, Hasbrouck Heights NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXH

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