FDA 510(k)

TWIN PLUS

K-Number: K012976 · 2002-02-12

Decision Date2002-02-12

Product CodeOLV

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TWIN PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Grass-Telefactor Divison. It received FDA 510(k) clearance on 2002-02-12 under 510(k) number K012976. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIN PLUS?

TWIN PLUS is a medical device that received FDA 510(k) clearance on 2002-02-12. The listed applicant is Grass-Telefactor Divison. The 510(k) number is K012976.

When did TWIN PLUS receive FDA 510(k) clearance?

TWIN PLUS received FDA 510(k) clearance on 2002-02-12, under 510(k) number K012976.

Who is the listed applicant for TWIN PLUS?

The FDA 510(k) record lists Grass-Telefactor Divison as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWIN PLUS?

The FDA product code for TWIN PLUS is OLV.

Related Devices (Code: OLV)

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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.