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FDA 510(k)

TONOPORT V

K-Number: K012647 · 2001-11-09

ApplicantPar Medizintechnik GmbH
Decision Date2001-11-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TONOPORT V is the device name listed in this FDA 510(k) record. The listed applicant is Par Medizintechnik GmbH. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012647. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONOPORT V?

TONOPORT V is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Par Medizintechnik GmbH. The 510(k) number is K012647.

When did TONOPORT V receive FDA 510(k) clearance?

TONOPORT V received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012647.

Who is the listed applicant for TONOPORT V?

The FDA 510(k) record lists Par Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TONOPORT V?

The FDA product code for TONOPORT V is DXN.

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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