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FDA 510(k)

BIOMEGA MODEL 59W

K-Number: K822438 · 1982-09-21

ApplicantBio Mega Diagnostic, Inc.
Decision Date1982-09-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOMEGA MODEL 59W 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 1982-09-21 under 510(k) number K822438. 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 BIOMEGA MODEL 59W?

BIOMEGA MODEL 59W is a medical device that received FDA 510(k) clearance on 1982-09-21. The listed applicant is Bio Mega Diagnostic, Inc.. The 510(k) number is K822438.

When did BIOMEGA MODEL 59W receive FDA 510(k) clearance?

BIOMEGA MODEL 59W received FDA 510(k) clearance on 1982-09-21, under 510(k) number K822438.

Who is the listed applicant for BIOMEGA MODEL 59W?

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 BIOMEGA MODEL 59W?

The FDA product code for BIOMEGA MODEL 59W is DXN.

Related Clinical Trials

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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 TSHK813556MOD. 587 BLOOD PRESSURE & PULSE MONITORK801923BIOMEGA #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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