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FDA 510(k)

RE-ENTRANT CHAMBER

K-Number: K013689 · 2002-07-02

ApplicantSun Nuclear Corp.
Decision Date2002-07-02
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RE-ENTRANT CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corp.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K013689. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RE-ENTRANT CHAMBER?

RE-ENTRANT CHAMBER is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Sun Nuclear Corp.. The 510(k) number is K013689.

When did RE-ENTRANT CHAMBER receive FDA 510(k) clearance?

RE-ENTRANT CHAMBER received FDA 510(k) clearance on 2002-07-02, under 510(k) number K013689.

Who is the listed applicant for RE-ENTRANT CHAMBER?

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

What is the FDA product code for RE-ENTRANT CHAMBER?

The FDA product code for RE-ENTRANT CHAMBER is KPT. This falls under the In Vitro Diagnostics category.

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Other records listing Sun Nuclear 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.

K112981SUN 125C IONIZATION CHAMBERK1019923D SCANNER, MODEL 1230K092019MODEL 1014 PC ELECTROMETERK063021PROFILER 2K051921THE EDGE DETECTOR, MODEL 1118K021463MODEL 1133 IVD PC VERSION

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Related Devices (Code: KPT)

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.

K192199CRC PC Smart Chamber K1Capintec, Inc.K162394CRC-77tHRCapintec, Inc.K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.K042746PET-DOSEComecer S.R.L.

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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