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FDA 510(k)

MOD. 587 BLOOD PRESSURE & PULSE MONITOR

K-Number: K813556 · 1982-01-22

ApplicantBio Mega Diagnostic, Inc.
Decision Date1982-01-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOD. 587 BLOOD PRESSURE & PULSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio Mega Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813556. 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 MOD. 587 BLOOD PRESSURE & PULSE MONITOR?

MOD. 587 BLOOD PRESSURE & PULSE MONITOR is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Bio Mega Diagnostic, Inc.. The 510(k) number is K813556.

When did MOD. 587 BLOOD PRESSURE & PULSE MONITOR receive FDA 510(k) clearance?

MOD. 587 BLOOD PRESSURE & PULSE MONITOR received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813556.

Who is the listed applicant for MOD. 587 BLOOD PRESSURE & PULSE MONITOR?

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

What is the FDA product code for MOD. 587 BLOOD PRESSURE & PULSE MONITOR?

The FDA product code for MOD. 587 BLOOD PRESSURE & PULSE MONITOR is DXN.

Related Clinical Trials

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.

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Other records listing Bio Mega Diagnostic, 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.

K864659BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSHK822438BIOMEGA MODEL 59WK801923BIOMEGA #423-B BLOOD PRESSURE & PULSE CKK760930BLOOD PRESSURE & PULSE CHECKER

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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