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FDA 510(k)

Respond OC Conserving Regulator (130-0800)

K-Number: K250322 · 2025-07-24

ApplicantResponsive Respiratory
Decision Date2025-07-24
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respond OC Conserving Regulator (130-0800) is a medical device manufactured by Responsive Respiratory. It received FDA 510(k) clearance on 2025-07-24 under approval number K250322. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Respond OC Conserving Regulator (130-0800)?

Respond OC Conserving Regulator (130-0800) is a medical device that received FDA 510(k) clearance on 2025-07-24. It is manufactured by Responsive Respiratory. The 510(k) number is K250322.

When was Respond OC Conserving Regulator (130-0800) approved by the FDA?

Respond OC Conserving Regulator (130-0800) received FDA 510(k) clearance on 2025-07-24, under approval number K250322.

What company makes Respond OC Conserving Regulator (130-0800)?

Respond OC Conserving Regulator (130-0800) is manufactured by Responsive Respiratory.

What is the FDA product code for Respond OC Conserving Regulator (130-0800)?

The FDA product code for Respond OC Conserving Regulator (130-0800) is NFB.

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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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