510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K901034Substantially Equivalent

Models Wep-8410A and Wep-8420A Telemetry Central

Nihon Kohden America Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901034 is the FDA 510(k) clearance record for MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K901034.

Clearance record

Decision date
Received
(44 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine CA
Third party review
No

Clearances, product code DRT

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