510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K945578Substantially Equivalent

Nihon Kohden Zb-821 Telemetry Transmitter

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

K945578 is the FDA 510(k) clearance record for NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K945578.

Clearance record

Decision date
Received
(365 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
Nihon Kohden America, Inc. 2601 Campus Dr., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code DRG

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