FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MagView BIOMAGNETOMETER SYSTEM
K Number: K152184
·
Decision Apr 8, 2016
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
3
Review Days
247
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Basic Information
- Device Name
- MagView BIOMAGNETOMETER SYSTEM
- K Number
- K152184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tristan Technologies, Inc.
- Date Received
- August 5, 2015
- Decision Date
- April 8, 2016
- Product Code
- OLY
- 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 |
|---|---|---|---|
| OLY | Magnetoencephalograph | FDA class 2 | Neurology |
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