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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 a medical device manufactured by Ventec Life Systems, Inc.. It received FDA 510(k) clearance on 2017-04-07 under approval 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. It is manufactured by Ventec Life Systems, Inc.. The 510(k) number is K162877.

When was VOCSN Unified Respiratory System approved by the FDA?

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

What company makes VOCSN Unified Respiratory System?

VOCSN Unified Respiratory System is manufactured by Ventec Life Systems, Inc..

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

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

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Related PubMed Literature

PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

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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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