FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIS EEG MONITOR, MODEL BISX4
K Number: K052981
·
Decision Nov 1, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
37
Applicant Total
25
Review Days
8
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Basic Information
- Device Name
- BIS EEG MONITOR, MODEL BISX4
- K Number
- K052981
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspect Medical Systems, Inc.
- Date Received
- October 24, 2005
- Decision Date
- November 1, 2005
- Product Code
- OLW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
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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Other Clearances by Aspect Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093183 | BIS QUATRO SENSOR | Oct 23, 2009 | Substantially Equivalent |
| K091854 | BIS CLICK SENSOR/CABLE | Jul 2, 2009 | Substantially Equivalent |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Nov 20, 2007 | Substantially Equivalent |
| K062613 | BIS EEG MONITOR VIEW | Jun 18, 2007 | Substantially Equivalent |
| K070069 | ZIPPREP ELECTRODE | Feb 5, 2007 | Substantially Equivalent |
| K062692 | BIS BILATERAL SENSOR | Dec 13, 2006 | Substantially Equivalent |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Sep 9, 2005 | Substantially Equivalent |
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | Feb 24, 2005 | Substantially Equivalent |
| K041670 | BIS PEDIATRIC SENSOR | Jul 6, 2004 | Substantially Equivalent |
| K040183 | BISX | Feb 25, 2004 | Substantially Equivalent |