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FDA 510(k)

SKALPI 3200

K-Number: K946382 · 1995-05-30

ApplicantWiscco Development, Inc.
Decision Date1995-05-30
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SKALPI 3200 is the device name listed in this FDA 510(k) record. The listed applicant is Wiscco Development, Inc.. It received FDA 510(k) clearance on 1995-05-30 under 510(k) number K946382. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKALPI 3200?

SKALPI 3200 is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Wiscco Development, Inc.. The 510(k) number is K946382.

When did SKALPI 3200 receive FDA 510(k) clearance?

SKALPI 3200 received FDA 510(k) clearance on 1995-05-30, under 510(k) number K946382.

Who is the listed applicant for SKALPI 3200?

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

What is the FDA product code for SKALPI 3200?

The FDA product code for SKALPI 3200 is IRO.

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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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