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FDA 510(k)

BIOSENSOR BIDOP VASCULAR TEST SYSTEM

K-Number: K943338 · 1996-04-12

ApplicantBiosensor Corp.
Decision Date1996-04-12
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOSENSOR BIDOP VASCULAR TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosensor Corp.. It received FDA 510(k) clearance on 1996-04-12 under 510(k) number K943338. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSENSOR BIDOP VASCULAR TEST SYSTEM?

BIOSENSOR BIDOP VASCULAR TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-12. The listed applicant is Biosensor Corp.. The 510(k) number is K943338.

When did BIOSENSOR BIDOP VASCULAR TEST SYSTEM receive FDA 510(k) clearance?

BIOSENSOR BIDOP VASCULAR TEST SYSTEM received FDA 510(k) clearance on 1996-04-12, under 510(k) number K943338.

Who is the listed applicant for BIOSENSOR BIDOP VASCULAR TEST SYSTEM?

The FDA 510(k) record lists Biosensor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSENSOR BIDOP VASCULAR TEST SYSTEM?

The FDA product code for BIOSENSOR BIDOP VASCULAR TEST SYSTEM is JAF.

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Other records listing Biosensor Corp. 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.

K990956BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005K974546BIOSENSOR HOLTER MONITOR SYSTEMK974192BIOSENSOR HOLTER MONITOR SYSTEMK950944AMBULATORY (HOLTER) RECORDING SYSTEMK960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)K950723AMBULATORY (HOLTER) RECORDING SYSTEM

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Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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