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FDA 510(k)

BO MED BIA

K-Number: K811999 · 1981-08-31

ApplicantBomed Medical Mfr., Ltd.
Decision Date1981-08-31
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BO MED BIA is the device name listed in this FDA 510(k) record. The listed applicant is Bomed Medical Mfr., Ltd.. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K811999. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BO MED BIA?

BO MED BIA is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Bomed Medical Mfr., Ltd.. The 510(k) number is K811999.

When did BO MED BIA receive FDA 510(k) clearance?

BO MED BIA received FDA 510(k) clearance on 1981-08-31, under 510(k) number K811999.

Who is the listed applicant for BO MED BIA?

The FDA 510(k) record lists Bomed Medical Mfr., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BO MED BIA?

The FDA product code for BO MED BIA is DSB.

Other records listing Bomed Medical Mfr., Ltd. 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.

K853706BOMED-CDMK853705BOMED-EEAK831421BOMED BIOCONK831422BIOFLOWK830792PULSETTE 110 TRANSCUTANEOUS ELEC-NERVEK813020BOMED-NCCOM

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Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, 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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