510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K852270Substantially Equivalent

Lifescope 8 Dec-8108A and Dec-8204A

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

K852270 is the FDA 510(k) clearance record for LIFESCOPE 8 DEC-8108A AND DEC-8204A, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K852270.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine CA
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI 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 DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260