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FDA 510(k)

Stimulation System (PA series, PR series, S series and Q series)

K-Number: K232786 · 2024-05-16

ApplicantEdan Instruments, Inc.
Decision Date2024-05-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Stimulation System (PA series, PR series, S series and Q series) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K232786. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stimulation System (PA series, PR series, S series and Q series)?

Stimulation System (PA series, PR series, S series and Q series) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K232786.

When did Stimulation System (PA series, PR series, S series and Q series) receive FDA 510(k) clearance?

Stimulation System (PA series, PR series, S series and Q series) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K232786.

Who is the listed applicant for Stimulation System (PA series, PR series, S series and Q series)?

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

What is the FDA product code for Stimulation System (PA series, PR series, S series and Q series)?

The FDA product code for Stimulation System (PA series, PR series, S series and Q series) is IPF.

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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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