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FDA 510(k)

D300 DOME

K-Number: K801136 · 1980-06-20

ApplicantGics Pharmaceuticals
Decision Date1980-06-20
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D300 DOME is the device name listed in this FDA 510(k) record. The listed applicant is Gics Pharmaceuticals. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801136. 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 D300 DOME?

D300 DOME is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Gics Pharmaceuticals. The 510(k) number is K801136.

When did D300 DOME receive FDA 510(k) clearance?

D300 DOME received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801136.

Who is the listed applicant for D300 DOME?

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

What is the FDA product code for D300 DOME?

The FDA product code for D300 DOME is DRS.

Other records listing Gics Pharmaceuticals 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.

K802890CPS-1000K801138MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.K800849TMS 1000 TEMP. MONITOR & PROBES

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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