FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K Number: K200630
·
Decision Apr 9, 2020
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
104
Applicant Total
209
Review Days
30
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Basic Information
- Device Name
- Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
- K Number
- K200630
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- March 10, 2020
- Decision Date
- April 9, 2020
- Product Code
- GWM
- 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
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