FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
K Number: K200848
·
Decision Aug 14, 2020
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
23
Applicant Total
1
Review Days
136
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Basic Information
- Device Name
- Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
- K Number
- K200848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micron Medical Corporation
- Date Received
- March 31, 2020
- Decision Date
- August 14, 2020
- Product Code
- GZF
- 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 |
|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | FDA class 2 | Neurology |
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