Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VASCULAB #R12B

K-Number: K812608 · 1981-10-02

ApplicantMedasonics, Inc.
Decision Date1981-10-02
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAB #R12B is the device name listed in this FDA 510(k) record. The listed applicant is Medasonics, Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812608. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAB #R12B?

VASCULAB #R12B is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Medasonics, Inc.. The 510(k) number is K812608.

When did VASCULAB #R12B receive FDA 510(k) clearance?

VASCULAB #R12B received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812608.

Who is the listed applicant for VASCULAB #R12B?

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 #R12B?

The FDA product code for VASCULAB #R12B is DSF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 19 devices →

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel 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.

↑