FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
HARMONE-SCHWARZER EEG SYSTEM
K Number: K010728
·
Decision May 21, 2001
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
7
Review Days
70
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Basic Information
- Device Name
- HARMONE-SCHWARZER EEG SYSTEM
- K Number
- K010728
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stellate Systems
- Date Received
- March 12, 2001
- Decision Date
- May 21, 2001
- Product Code
- OLV
- 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 |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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