FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iovera system
K Number: K161835
·
Decision Mar 24, 2017
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
22
Applicant Total
3
Review Days
262
Basic Information
- Device Name
- iovera system
- K Number
- K161835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Myoscience, Inc
- Date Received
- July 5, 2016
- Decision Date
- March 24, 2017
- Product Code
- GXH
- 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 |
|---|---|---|---|
| GXH | Device, Surgical, Cryogenic | FDA class 2 | Neurology |
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