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FDA 510(k)

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601

K-Number: K920778 · 1992-12-24

ApplicantOmron Healthcare, Inc.
Decision Date1992-12-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K920778. 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 OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601?

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K920778.

When did OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 receive FDA 510(k) clearance?

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 received FDA 510(k) clearance on 1992-12-24, under 510(k) number K920778.

Who is the listed applicant for OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601?

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

What is the FDA product code for OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601?

The FDA product code for OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 is DXN.

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Other records listing Omron Healthcare, Inc. as applicant

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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

View on FDA Database →

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

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