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FDA 510(k)

OMRON DIGITAL BP MONITOR HEM-400C

K-Number: K851707 · 1985-07-31

ApplicantOmron Tateisi Electronics Co.
Decision Date1985-07-31
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMRON DIGITAL BP MONITOR HEM-400C is the device name listed in this FDA 510(k) record. The listed applicant is Omron Tateisi Electronics Co.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K851707. 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 DIGITAL BP MONITOR HEM-400C?

OMRON DIGITAL BP MONITOR HEM-400C is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is Omron Tateisi Electronics Co.. The 510(k) number is K851707.

When did OMRON DIGITAL BP MONITOR HEM-400C receive FDA 510(k) clearance?

OMRON DIGITAL BP MONITOR HEM-400C received FDA 510(k) clearance on 1985-07-31, under 510(k) number K851707.

Who is the listed applicant for OMRON DIGITAL BP MONITOR HEM-400C?

The FDA 510(k) record lists Omron Tateisi Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMRON DIGITAL BP MONITOR HEM-400C?

The FDA product code for OMRON DIGITAL BP MONITOR HEM-400C is DXN.

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Other records listing Omron Tateisi Electronics Co. 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.

K881601OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403CK881602OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703CK871371DIGITAL SPHYGMOMANOMETERK864466OMRON ULTRASONIC NEBULIZER MODEL NE-UO5K854201OMRON DIGITAL BP MONITOR HEM-700CPK853260OMRON DIGITAL BP MONITOR HEM-700C

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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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