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FDA 510(k)

EGS4000

K-Number: K955666 · 1997-04-15

Decision Date1997-04-15
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EGS4000 is the device name listed in this FDA 510(k) record. The listed applicant is S&P Electrical Industries, Inc.. It received FDA 510(k) clearance on 1997-04-15 under 510(k) number K955666. 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 EGS4000?

EGS4000 is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is S&P Electrical Industries, Inc.. The 510(k) number is K955666.

When did EGS4000 receive FDA 510(k) clearance?

EGS4000 received FDA 510(k) clearance on 1997-04-15, under 510(k) number K955666.

Who is the listed applicant for EGS4000?

The FDA 510(k) record lists S&P Electrical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EGS4000?

The FDA product code for EGS4000 is IPF.

Related Devices (Code: IPF)

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.

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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