FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Respond OC Conserving Regulator (130-0800)
K Number: K250322
·
Decision Jul 24, 2025
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
1
Review Days
170
Basic Information
- Device Name
- Respond OC Conserving Regulator (130-0800)
- K Number
- K250322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Responsive Respiratory
- Date Received
- February 4, 2025
- Decision Date
- July 24, 2025
- Product Code
- NFB
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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