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FDA 510(k)

FLOSCOPE SUPER VASCULAR LAB

K-Number: K943200 · 1995-11-21

ApplicantAdvance Medical Device, Inc.
Decision Date1995-11-21
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLOSCOPE SUPER VASCULAR LAB is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Device, Inc.. It received FDA 510(k) clearance on 1995-11-21 under 510(k) number K943200. 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 FLOSCOPE SUPER VASCULAR LAB?

FLOSCOPE SUPER VASCULAR LAB is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Advance Medical Device, Inc.. The 510(k) number is K943200.

When did FLOSCOPE SUPER VASCULAR LAB receive FDA 510(k) clearance?

FLOSCOPE SUPER VASCULAR LAB received FDA 510(k) clearance on 1995-11-21, under 510(k) number K943200.

Who is the listed applicant for FLOSCOPE SUPER VASCULAR LAB?

The FDA 510(k) record lists Advance Medical Device, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOSCOPE SUPER VASCULAR LAB?

The FDA product code for FLOSCOPE SUPER VASCULAR LAB is JAF.

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 Advance Medical Device, 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.

K964697AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATIONK910441FLOSCOPE MICRODOPK905157FLOSCOPE VASCULAR LAB.K903744PHYSICIAN'S CHOICE

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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