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FDA 510(k)

BIOFLOW

K-Number: K831422 · 1983-09-12

ApplicantBomed Medical Mfr., Ltd.
Decision Date1983-09-12
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOFLOW 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 1983-09-12 under 510(k) number K831422. 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 BIOFLOW?

BIOFLOW is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Bomed Medical Mfr., Ltd.. The 510(k) number is K831422.

When did BIOFLOW receive FDA 510(k) clearance?

BIOFLOW received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831422.

Who is the listed applicant for BIOFLOW?

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 BIOFLOW?

The FDA product code for BIOFLOW is DSB.

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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 BIOCONK830792PULSETTE 110 TRANSCUTANEOUS ELEC-NERVEK813020BOMED-NCCOMK811999BO MED BIA

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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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