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FDA 510(k)

DISPOSABLE, STERILE TRANSDUCER DOMES

K-Number: K810735 · 1981-05-08

ApplicantBio-Med Corp.
Decision Date1981-05-08
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, STERILE TRANSDUCER DOMES 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 1981-05-08 under 510(k) number K810735. 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 DISPOSABLE, STERILE TRANSDUCER DOMES?

DISPOSABLE, STERILE TRANSDUCER DOMES is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Bio-Med Corp.. The 510(k) number is K810735.

When did DISPOSABLE, STERILE TRANSDUCER DOMES receive FDA 510(k) clearance?

DISPOSABLE, STERILE TRANSDUCER DOMES received FDA 510(k) clearance on 1981-05-08, under 510(k) number K810735.

Who is the listed applicant for DISPOSABLE, STERILE TRANSDUCER DOMES?

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 DISPOSABLE, STERILE TRANSDUCER DOMES?

The FDA product code for DISPOSABLE, STERILE TRANSDUCER DOMES is DRS.

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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 1000NSK802092HF-100 DIALYZERK801985BIO-MED CORP. DISP. NON-STERILE TRANSDUK802069DISP. TRANSDUCER DOMES TD200 & TD300

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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