FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INOmax DSIR Plus
K Number: K200389
·
Decision Jun 17, 2020
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
4
Review Days
120
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INOmax DSIR Plus
- K Number
- K200389
- 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
- February 18, 2020
- Decision Date
- June 17, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRN), ordered by most recent decision date.
ULSPIRA TS Nitric Oxide Therapy System
FDA 510(k)
FDA Class 2
·Anesthesiology
EVOLVE Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
EVOLVE Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
NOxBOXi Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
Evolve Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
NOxBOXi Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology