510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062469Substantially Equivalent

Voyager 12

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

K062469 is the FDA 510(k) clearance record for VOYAGER 12, a class II device, cleared for Del Mar Reynolds Medical, Ltd. on under FDA product code DPS (Electrocardiograph). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K062469.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
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 DPS

Trailing 12 months
7 clearances under product code DPS in the twelve months to November 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20262
November 20260