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FDA 510(k)

STATNET

K-Number: K970525 · 1997-04-16

ApplicantGorca Systems, Inc.
Decision Date1997-04-16
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STATNET is the device name listed in this FDA 510(k) record. The listed applicant is Gorca Systems, Inc.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K970525. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATNET?

STATNET is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Gorca Systems, Inc.. The 510(k) number is K970525.

When did STATNET receive FDA 510(k) clearance?

STATNET received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970525.

Who is the listed applicant for STATNET?

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

What is the FDA product code for STATNET?

The FDA product code for STATNET is IZI.

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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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