FDA 510(k)

ONE-STEP PLUS

K-Number: K011159 · 2001-06-08

Decision Date2001-06-08

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ONE-STEP PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K011159. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE-STEP PLUS?

ONE-STEP PLUS is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Bisco, Inc.. The 510(k) number is K011159.

When did ONE-STEP PLUS receive FDA 510(k) clearance?

ONE-STEP PLUS received FDA 510(k) clearance on 2001-06-08, under 510(k) number K011159.

Who is the listed applicant for ONE-STEP PLUS?

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 ONE-STEP PLUS?

The FDA product code for ONE-STEP PLUS is EMA.

Other records listing Bisco, Inc. as applicant

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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.