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FDA 510(k)

ACCUTRACKER HEART-RATE MONITOR

K-Number: K850867 · 1985-05-16

ApplicantEutectic Electronics, Inc.
Decision Date1985-05-16
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUTRACKER HEART-RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Eutectic Electronics, Inc.. It received FDA 510(k) clearance on 1985-05-16 under 510(k) number K850867. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTRACKER HEART-RATE MONITOR?

ACCUTRACKER HEART-RATE MONITOR is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is Eutectic Electronics, Inc.. The 510(k) number is K850867.

When did ACCUTRACKER HEART-RATE MONITOR receive FDA 510(k) clearance?

ACCUTRACKER HEART-RATE MONITOR received FDA 510(k) clearance on 1985-05-16, under 510(k) number K850867.

Who is the listed applicant for ACCUTRACKER HEART-RATE MONITOR?

The FDA 510(k) record lists Eutectic Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUTRACKER HEART-RATE MONITOR?

The FDA product code for ACCUTRACKER HEART-RATE MONITOR is DXN.

Related Clinical Trials

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Other records listing Eutectic Electronics, Inc. as applicant

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.

K894968ULTRACOMPACT

Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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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