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)

DISP. TRANSDUCER DOMES TD200 & TD300

K-Number: K802069 · 1980-09-09

ApplicantBio-Med Corp.
Decision Date1980-09-09
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISP. TRANSDUCER DOMES TD200 & TD300 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Corp.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K802069. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISP. TRANSDUCER DOMES TD200 & TD300?

DISP. TRANSDUCER DOMES TD200 & TD300 is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Bio-Med Corp.. The 510(k) number is K802069.

When did DISP. TRANSDUCER DOMES TD200 & TD300 receive FDA 510(k) clearance?

DISP. TRANSDUCER DOMES TD200 & TD300 received FDA 510(k) clearance on 1980-09-09, under 510(k) number K802069.

Who is the listed applicant for DISP. TRANSDUCER DOMES TD200 & TD300?

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

What is the FDA product code for DISP. TRANSDUCER DOMES TD200 & TD300?

The FDA product code for DISP. TRANSDUCER DOMES TD200 & TD300 is DRS.

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 Bio-Med 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.

K823286MODELS DPT 1000/DPT 1000NSK810735DISPOSABLE, STERILE TRANSDUCER DOMESK802092HF-100 DIALYZERK801985BIO-MED CORP. DISP. NON-STERILE TRANSDU

Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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.

↑