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FDA 510(k)

TONOPORT VI

K-Number: K170966 · 2017-06-14

ApplicantPar Medizintechnik GmbH & Co. KG
Decision Date2017-06-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TONOPORT VI is the device name listed in this FDA 510(k) record. The listed applicant is Par Medizintechnik GmbH & Co. KG. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K170966. 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 VI?

TONOPORT VI is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Par Medizintechnik GmbH & Co. KG. The 510(k) number is K170966.

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

TONOPORT VI received FDA 510(k) clearance on 2017-06-14, under 510(k) number K170966.

Who is the listed applicant for TONOPORT VI?

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

What is the FDA product code for TONOPORT VI?

The FDA product code for TONOPORT VI is DXN.

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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