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FDA 510(k)

EQUAL DOSE 1.0

K-Number: K073273 · 2007-12-11

ApplicantNucletron Corporation
Decision Date2007-12-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EQUAL DOSE 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2007-12-11 under 510(k) number K073273. 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 EQUAL DOSE 1.0?

EQUAL DOSE 1.0 is a medical device that received FDA 510(k) clearance on 2007-12-11. The listed applicant is Nucletron Corporation. The 510(k) number is K073273.

When did EQUAL DOSE 1.0 receive FDA 510(k) clearance?

EQUAL DOSE 1.0 received FDA 510(k) clearance on 2007-12-11, under 510(k) number K073273.

Who is the listed applicant for EQUAL DOSE 1.0?

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

What is the FDA product code for EQUAL DOSE 1.0?

The FDA product code for EQUAL DOSE 1.0 is IYE.

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Other records listing Nucletron Corporation 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.

K103515EQUAL DOSEK090706ONCENTRA SIMULATION 2.3K091154UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,K082642ONCENTRA RT VIEWER 1.0K080934VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SETK081281OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)

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Related Devices (Code: IYE)

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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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