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FDA 510(k)

VOCSN Unified Respiratory System

K-Number: K162877 · 2017-04-07

ApplicantVentec Life Systems, Inc.
Decision Date2017-04-07
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VOCSN Unified Respiratory System is the device name listed in this FDA 510(k) record. The listed applicant is Ventec Life Systems, Inc.. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K162877. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOCSN Unified Respiratory System?

VOCSN Unified Respiratory System is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Ventec Life Systems, Inc.. The 510(k) number is K162877.

When did VOCSN Unified Respiratory System receive FDA 510(k) clearance?

VOCSN Unified Respiratory System received FDA 510(k) clearance on 2017-04-07, under 510(k) number K162877.

Who is the listed applicant for VOCSN Unified Respiratory System?

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

What is the FDA product code for VOCSN Unified Respiratory System?

The FDA product code for VOCSN Unified Respiratory System is CBK.

Related Devices (Code: CBK)

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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