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FDA 510(k)

PNEUMO-WEDGE

K-Number: K921143 · 1992-09-11

ApplicantKansas Creative Devices, Inc.
Decision Date1992-09-11
Product CodeFQO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PNEUMO-WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is Kansas Creative Devices, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K921143. The device is classified under product code FQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMO-WEDGE?

PNEUMO-WEDGE is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Kansas Creative Devices, Inc.. The 510(k) number is K921143.

When did PNEUMO-WEDGE receive FDA 510(k) clearance?

PNEUMO-WEDGE received FDA 510(k) clearance on 1992-09-11, under 510(k) number K921143.

Who is the listed applicant for PNEUMO-WEDGE?

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

What is the FDA product code for PNEUMO-WEDGE?

The FDA product code for PNEUMO-WEDGE is FQO.

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Related Devices (Code: FQO)

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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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