FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K Number: K060900
·
Decision Jun 23, 2006
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
37
Applicant Total
35
Review Days
81
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Basic Information
- Device Name
- SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
- K Number
- K060900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spacelabs Medical, Inc.
- Date Received
- April 3, 2006
- Decision Date
- June 23, 2006
- 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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Other Clearances by Spacelabs Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 | Mar 29, 2012 | Substantially Equivalent |
| K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) | Nov 2, 2011 | Substantially Equivalent |
| K102422 | SPACELABS MEDICAL PATIENT MONITORS | Dec 7, 2010 | Substantially Equivalent |
| K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION | Nov 24, 2009 | Substantially Equivalent |
| K082045 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | Aug 1, 2008 | Substantially Equivalent |
| K063490 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 | Mar 15, 2007 | Substantially Equivalent |
| K062095 | MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | Sep 29, 2006 | Substantially Equivalent |
| K062278 | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 | Sep 19, 2006 | Substantially Equivalent |
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | Apr 19, 2006 | Substantially Equivalent |
| K050605 | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 | May 3, 2005 | Substantially Equivalent |