510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K823281Substantially Equivalent

Model Rm 6000, 6100,6200 Polygraph

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

K823281 is the FDA 510(k) clearance record for MODEL RM 6000, 6100,6200 POLYGRAPH, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K823281.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Nihon Kohden America, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DPS

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