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FDA 510(k)

VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON

K-Number: K971541 · 1997-06-25

ApplicantHollister, Inc.
Decision Date1997-06-25
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K971541. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON?

VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Hollister, Inc.. The 510(k) number is K971541.

When did VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON receive FDA 510(k) clearance?

VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971541.

Who is the listed applicant for VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON?

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

What is the FDA product code for VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON?

The FDA product code for VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON is KPI.

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Related Devices (Code: KPI)

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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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