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FDA 510(k)

PERIFORM PERINEOMETRIC PROBE, MODEL 8300

K-Number: K002617 · 2001-04-05

ApplicantNeen Design , Ltd.
Decision Date2001-04-05
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERIFORM PERINEOMETRIC PROBE, MODEL 8300 is the device name listed in this FDA 510(k) record. The listed applicant is Neen Design , Ltd.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K002617. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIFORM PERINEOMETRIC PROBE, MODEL 8300?

PERIFORM PERINEOMETRIC PROBE, MODEL 8300 is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Neen Design , Ltd.. The 510(k) number is K002617.

When did PERIFORM PERINEOMETRIC PROBE, MODEL 8300 receive FDA 510(k) clearance?

PERIFORM PERINEOMETRIC PROBE, MODEL 8300 received FDA 510(k) clearance on 2001-04-05, under 510(k) number K002617.

Who is the listed applicant for PERIFORM PERINEOMETRIC PROBE, MODEL 8300?

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

What is the FDA product code for PERIFORM PERINEOMETRIC PROBE, MODEL 8300?

The FDA product code for PERIFORM PERINEOMETRIC PROBE, MODEL 8300 is HIR.

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Related Devices (Code: HIR)

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

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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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