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FDA 510(k)

S2MEDIAN

K-Number: K832295 · 1983-08-31

ApplicantAnstek Corp.
Decision Date1983-08-31
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

S2MEDIAN is the device name listed in this FDA 510(k) record. The listed applicant is Anstek Corp.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832295. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S2MEDIAN?

S2MEDIAN is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Anstek Corp.. The 510(k) number is K832295.

When did S2MEDIAN receive FDA 510(k) clearance?

S2MEDIAN received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832295.

Who is the listed applicant for S2MEDIAN?

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

What is the FDA product code for S2MEDIAN?

The FDA product code for S2MEDIAN is GXY.

Related Clinical Trials

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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Other records listing Anstek Corp. as applicant

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.

K832296S2 POSTERIOR-TIB

Related Devices (Code: GXY)

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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