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FDA 510(k)

VASCULAB BI-DIRECTIONAL DOPPLER, #D10

K-Number: K800768 · 1980-07-08

ApplicantMedasonics, Inc.
Decision Date1980-07-08
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VASCULAB BI-DIRECTIONAL DOPPLER, #D10 is the device name listed in this FDA 510(k) record. The listed applicant is Medasonics, Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K800768. 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 VASCULAB BI-DIRECTIONAL DOPPLER, #D10?

VASCULAB BI-DIRECTIONAL DOPPLER, #D10 is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Medasonics, Inc.. The 510(k) number is K800768.

When did VASCULAB BI-DIRECTIONAL DOPPLER, #D10 receive FDA 510(k) clearance?

VASCULAB BI-DIRECTIONAL DOPPLER, #D10 received FDA 510(k) clearance on 1980-07-08, under 510(k) number K800768.

Who is the listed applicant for VASCULAB BI-DIRECTIONAL DOPPLER, #D10?

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

What is the FDA product code for VASCULAB BI-DIRECTIONAL DOPPLER, #D10?

The FDA product code for VASCULAB BI-DIRECTIONAL DOPPLER, #D10 is JAF.

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Other records listing Medasonics, 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.

K991441CADENCE DOPPLER ULTRASOUND SYSTEMK962796NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEMK961116FIRST BEAT/CARDIO BEAT/CALCK914862CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDSK911453OBTRASOUND STETHOSCOPE FETAL CALCK882018MEDACORD PVL, PERSONAL VASCULAR LABORATORY

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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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