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FDA 510(k)

PVS MODEL 1.0

K-Number: K102237 · 2010-11-23

ApplicantMedcom GmbH
Decision Date2010-11-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PVS MODEL 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K102237. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVS MODEL 1.0?

PVS MODEL 1.0 is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Medcom GmbH. The 510(k) number is K102237.

When did PVS MODEL 1.0 receive FDA 510(k) clearance?

PVS MODEL 1.0 received FDA 510(k) clearance on 2010-11-23, under 510(k) number K102237.

Who is the listed applicant for PVS MODEL 1.0?

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

What is the FDA product code for PVS MODEL 1.0?

The FDA product code for PVS MODEL 1.0 is IYE.

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Other records listing Medcom GmbH as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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