FDA 510(k)

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

K-Number: K101831 · 2010-10-01

Decision Date2010-10-01

Product CodeOSL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2010-10-01 under 510(k) number K101831. The device is classified under product code OSL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800?

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 is a medical device that received FDA 510(k) clearance on 2010-10-01. The listed applicant is Bionostics, Inc.. The 510(k) number is K101831.

When did ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 receive FDA 510(k) clearance?

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 received FDA 510(k) clearance on 2010-10-01, under 510(k) number K101831.

Who is the listed applicant for ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800?

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

What is the FDA product code for ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800?

The FDA product code for ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 is OSL.

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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.