FDA 510(k)

ALL-IN-ONE

K-Number: K050647 · 2005-04-20

Decision Date2005-04-20

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ALL-IN-ONE is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2005-04-20 under 510(k) number K050647. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL-IN-ONE?

ALL-IN-ONE is a medical device that received FDA 510(k) clearance on 2005-04-20. The listed applicant is Bisco, Inc.. The 510(k) number is K050647.

When did ALL-IN-ONE receive FDA 510(k) clearance?

ALL-IN-ONE received FDA 510(k) clearance on 2005-04-20, under 510(k) number K050647.

Who is the listed applicant for ALL-IN-ONE?

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

What is the FDA product code for ALL-IN-ONE?

The FDA product code for ALL-IN-ONE is KLE.

Other records listing Bisco, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.