FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Unity Subcutaneous Delivery System for Remodulin
K Number: K190182
·
Decision May 6, 2019
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
3
Review Days
94
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Basic Information
- Device Name
- Unity Subcutaneous Delivery System for Remodulin
- K Number
- K190182
- 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 & Development
- Date Received
- February 1, 2019
- Decision Date
- May 6, 2019
- 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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