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FDA 510(k)

SEP-10S PLUS, AND SP-12S PRO.

K-Number: K010937 · 2001-06-25

ApplicantViltechmeda
Decision Date2001-06-25
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEP-10S PLUS, AND SP-12S PRO. is the device name listed in this FDA 510(k) record. The listed applicant is Viltechmeda. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K010937. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEP-10S PLUS, AND SP-12S PRO.?

SEP-10S PLUS, AND SP-12S PRO. is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Viltechmeda. The 510(k) number is K010937.

When did SEP-10S PLUS, AND SP-12S PRO. receive FDA 510(k) clearance?

SEP-10S PLUS, AND SP-12S PRO. received FDA 510(k) clearance on 2001-06-25, under 510(k) number K010937.

Who is the listed applicant for SEP-10S PLUS, AND SP-12S PRO.?

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

What is the FDA product code for SEP-10S PLUS, AND SP-12S PRO.?

The FDA product code for SEP-10S PLUS, AND SP-12S PRO. is FRN.

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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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