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FDA 510(k)

MINI-DOPPLER ES-100

K-Number: K840542 · 1984-07-16

ApplicantHayashi Denki Co., Ltd.
Decision Date1984-07-16
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI-DOPPLER ES-100 is the device name listed in this FDA 510(k) record. The listed applicant is Hayashi Denki Co., Ltd.. It received FDA 510(k) clearance on 1984-07-16 under 510(k) number K840542. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI-DOPPLER ES-100?

MINI-DOPPLER ES-100 is a medical device that received FDA 510(k) clearance on 1984-07-16. The listed applicant is Hayashi Denki Co., Ltd.. The 510(k) number is K840542.

When did MINI-DOPPLER ES-100 receive FDA 510(k) clearance?

MINI-DOPPLER ES-100 received FDA 510(k) clearance on 1984-07-16, under 510(k) number K840542.

Who is the listed applicant for MINI-DOPPLER ES-100?

The FDA 510(k) record lists Hayashi Denki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI-DOPPLER ES-100?

The FDA product code for MINI-DOPPLER ES-100 is JOP.

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Related Devices (Code: JOP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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