FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYSTAL MONITOR MODEL 16
K Number: K013863
·
Decision Feb 19, 2002
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
27
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- CRYSTAL MONITOR MODEL 16
- K Number
- K013863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cleveland Medical Devices, Inc.
- Date Received
- November 21, 2001
- Decision Date
- February 19, 2002
- Product Code
- OMC
- 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 |
|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Cleveland Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063872 | KINESIA | Apr 6, 2007 | Substantially Equivalent |
| K042039 | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 | Nov 17, 2004 | Substantially Equivalent |
| K001110 | CRYSTAL-EEG MODEL 15 | Jul 5, 2000 | Substantially Equivalent |
| K970672 | CRYSTAL-EEG MODEL 10 (MODEL 10) | May 22, 1997 | Substantially Equivalent |
| K964690 | LIBERTY VALVE | Mar 21, 1997 | Substantially Equivalent |
| K962591 | FOOT WEIGHT ALARM | Dec 4, 1996 | Substantially Equivalent |
| K954670 | PRESSORE MONITOR | Oct 30, 1995 | Substantially Equivalent |