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FDA 510(k)

BIO-MED CORP. DISP. NON-STERILE TRANSDU

K-Number: K801985 · 1980-09-09

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

Device Summary

BIO-MED CORP. DISP. NON-STERILE TRANSDU 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 K801985. 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 BIO-MED CORP. DISP. NON-STERILE TRANSDU?

BIO-MED CORP. DISP. NON-STERILE TRANSDU 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 K801985.

When did BIO-MED CORP. DISP. NON-STERILE TRANSDU receive FDA 510(k) clearance?

BIO-MED CORP. DISP. NON-STERILE TRANSDU received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801985.

Who is the listed applicant for BIO-MED CORP. DISP. NON-STERILE TRANSDU?

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 BIO-MED CORP. DISP. NON-STERILE TRANSDU?

The FDA product code for BIO-MED CORP. DISP. NON-STERILE TRANSDU 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.

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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 1000NSK810735DISPOSABLE, STERILE TRANSDUCER DOMESK802092HF-100 DIALYZERK802069DISP. 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.

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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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