FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Orion LifeSpan MEG
K Number: K191785
·
Decision Feb 14, 2020
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
9
Review Days
226
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Basic Information
- Device Name
- Orion LifeSpan MEG
- K Number
- K191785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compumedics Limited
- Date Received
- July 3, 2019
- Decision Date
- February 14, 2020
- 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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