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FDA 510(k)

UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR

K-Number: K951764 · 1995-10-07

ApplicantPtw-New York Corp.
Decision Date1995-10-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-New York Corp.. It received FDA 510(k) clearance on 1995-10-07 under 510(k) number K951764. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR?

UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Ptw-New York Corp.. The 510(k) number is K951764.

When did UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR receive FDA 510(k) clearance?

UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR received FDA 510(k) clearance on 1995-10-07, under 510(k) number K951764.

Who is the listed applicant for UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR?

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

What is the FDA product code for UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR?

The FDA product code for UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR is IYE.

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Other records listing Ptw-New York 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.

K062817PTW DAVID IMRT QC VERIFICATION SYSTEMK010705OPTIDOSK010916PTW DOSIMETRY DIODE, T60008K972211MULTIDOS, QC6PLUSK9722120.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBERK9612080.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER

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Related Devices (Code: IYE)

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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