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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 the device name listed in this FDA 510(k) record. The listed applicant is Responsive Respiratory. It received FDA 510(k) clearance on 2025-07-24 under 510(k) 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. The listed applicant is Responsive Respiratory. The 510(k) number is K250322.

When did Respond OC Conserving Regulator (130-0800) receive FDA 510(k) clearance?

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

Who is the listed applicant for Respond OC Conserving Regulator (130-0800)?

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

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.

Related Devices (Code: NFB)

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.

K220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs

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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