FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOLVE Nitric Oxide Delivery System
K Number: K242578
·
Decision Jan 3, 2025
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
4
Review Days
127
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Basic Information
- Device Name
- EVOLVE Nitric Oxide Delivery System
- K Number
- K242578
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5165
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mallinckrodt Manufacturing, LLC
- Date Received
- August 29, 2024
- Decision Date
- January 3, 2025
- Product Code
- MRN
- 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 |
|---|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | FDA class 2 | Anesthesiology |
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