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FDA 510(k)

REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002

K-Number: K022739 · 2002-10-25

ApplicantNucletron Corporation
Decision Date2002-10-25
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2002-10-25 under 510(k) number K022739. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002?

REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 is a medical device that received FDA 510(k) clearance on 2002-10-25. The listed applicant is Nucletron Corporation. The 510(k) number is K022739.

When did REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 receive FDA 510(k) clearance?

REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 received FDA 510(k) clearance on 2002-10-25, under 510(k) number K022739.

Who is the listed applicant for REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002?

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 REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002?

The FDA product code for REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 is JAQ.

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Related Devices (Code: JAQ)

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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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