FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Praxiject SP 0.9% NaCl
K Number: K233623
·
Decision Feb 27, 2024
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
39
Applicant Total
4
Review Days
106
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Basic Information
- Device Name
- Praxiject SP 0.9% NaCl
- K Number
- K233623
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medxl, Inc.
- Date Received
- November 13, 2023
- Decision Date
- February 27, 2024
- Product Code
- NGT
- 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 |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | FDA class 2 | General Hospital |
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