FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIS SRS (SEMI-RESUABLE SENSOR)
K Number: K050313
·
Decision Feb 24, 2005
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
4
Applicant Total
25
Review Days
15
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Basic Information
- Device Name
- BIS SRS (SEMI-RESUABLE SENSOR)
- K Number
- K050313
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1750
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspect Medical Systems, Inc.
- Date Received
- February 9, 2005
- Decision Date
- February 24, 2005
- Product Code
- GWY
- 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 |
|---|---|---|---|
| GWY | Pinwheel | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWY), ordered by most recent decision date.
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1-380 PINWHEEL (WARTENBERG)
FDA 510(k)
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PINWHEEL
FDA 510(k)
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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 |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | Nov 1, 2005 | Substantially Equivalent |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Sep 9, 2005 | Substantially Equivalent |
| K041670 | BIS PEDIATRIC SENSOR | Jul 6, 2004 | Substantially Equivalent |
| K040183 | BISX | Feb 25, 2004 | Substantially Equivalent |