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FDA 510(k)

NEOGEN PSR SYSTEM

K-Number: K132754 · 2013-12-12

ApplicantEnergist, Ltd.
Decision Date2013-12-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEOGEN PSR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Energist, Ltd.. It received FDA 510(k) clearance on 2013-12-12 under 510(k) number K132754. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOGEN PSR SYSTEM?

NEOGEN PSR SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-12. The listed applicant is Energist, Ltd.. The 510(k) number is K132754.

When did NEOGEN PSR SYSTEM receive FDA 510(k) clearance?

NEOGEN PSR SYSTEM received FDA 510(k) clearance on 2013-12-12, under 510(k) number K132754.

Who is the listed applicant for NEOGEN PSR SYSTEM?

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

What is the FDA product code for NEOGEN PSR SYSTEM?

The FDA product code for NEOGEN PSR SYSTEM is GEI.

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Other records listing Energist, Ltd. 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.

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Related Devices (Code: GEI)

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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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