Respond OC Conserving Regulator (130-0800)— 510(k) K250322

Name: FDA 510(k) clearance K250322
Creator: U.S. Food and Drug Administration
Published: 2025-07-24

Substantially Equivalent

Responsive Respiratory

FDA 510(k) clearance K250322 for Respond OC Conserving Regulator (130-0800), Substantially Equivalent on 2025-07-24. Applicant: Responsive Respiratory. Device class: 2.

Clearance details

Applicant: Responsive Respiratory
Product code: Code NFB
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2025-02-04
Decision date: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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