FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K Number: K241736
·
Decision Jan 16, 2025
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
1
Review Days
213
Basic Information
- Device Name
- Remunity 2.0 Pump for Remodulin (treprostinil) Injection
- K Number
- K241736
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEKA Research and Development Corp.
- Date Received
- June 17, 2024
- Decision Date
- January 16, 2025
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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