FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K Number: K050835
·
Decision May 6, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
37
Applicant Total
168
Review Days
35
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Basic Information
- Device Name
- DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
- K Number
- K050835
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Healthcare
- Date Received
- April 1, 2005
- Decision Date
- May 6, 2005
- Product Code
- OLW
- 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 |
|---|---|---|---|
| OLW | Index-Generating Electroencephalograph Software | FDA class 2 | Neurology |
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