FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smart External Drain (SED) System
K Number: K172759
·
Decision Nov 14, 2017
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
4
Review Days
62
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Basic Information
- Device Name
- Smart External Drain (SED) System
- K Number
- K172759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aqueduct Critical Care, Inc.
- Date Received
- September 13, 2017
- Decision Date
- November 14, 2017
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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