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FDA 510(k)

RESPOND(R) Ventilator

K-Number: K241135 · 2024-11-13

ApplicantCorvent Medical, Inc.
Decision Date2024-11-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPOND(R) Ventilator is a medical device manufactured by Corvent Medical, Inc.. It received FDA 510(k) clearance on 2024-11-13 under approval number K241135. 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 RESPOND(R) Ventilator?

RESPOND(R) Ventilator is a medical device that received FDA 510(k) clearance on 2024-11-13. It is manufactured by Corvent Medical, Inc.. The 510(k) number is K241135.

When was RESPOND(R) Ventilator approved by the FDA?

RESPOND(R) Ventilator received FDA 510(k) clearance on 2024-11-13, under approval number K241135.

What company makes RESPOND(R) Ventilator?

RESPOND(R) Ventilator is manufactured by Corvent Medical, Inc..

What is the FDA product code for RESPOND(R) Ventilator?

The FDA product code for RESPOND(R) Ventilator is CBK.

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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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