510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840542Substantially Equivalent

Mini-Doppler Es-100

Hayashi Denki Co., Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840542 is the FDA 510(k) clearance record for MINI-DOPPLER ES-100, a class II device, cleared for Hayashi Denki Co., Ltd. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list one 510(k) clearance for Hayashi Denki Co., Ltd. As of , FDA records show no recalls naming K840542.

Clearance record

Decision date
Received
(159 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Hayashi Denki Co., Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JOP

Trailing 12 months

FDA records hold no clearances under product code JOP in the trailing twelve months.

FDA records show no clearances under product code JOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260