510(k) K250322
K250322 is an FDA 510(k) premarket notification submitted by Responsive Respiratory for the device "Respond OC Conserving Regulator (130-0800)". The FDA issued a decision of Substantially Equivalent on July 24, 2025. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Responsive Respiratory has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2025
- Date Received
- February 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conserver, Oxygen
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type