510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130971Substantially Equivalent

Optum Telehealth Application

Optum Distribution Center, LLC, Dundas, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130971 is the FDA 510(k) clearance record for OPTUM TELEHEALTH APPLICATION, a class II device, cleared for Optumhealth Care Solutions, Inc. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list one 510(k) clearance for Optum Distribution Center, LLC. As of , FDA records show no recalls naming K130971.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
Optumhealth Care Solutions, Inc. 4 Innovation Dr., Dundas, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260