FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOM ELECTRODES
K Number: K071631
·
Decision Jan 18, 2008
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
7
Review Days
218
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Basic Information
- Device Name
- NICOM ELECTRODES
- K Number
- K071631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cheetah Medical, Inc.
- Date Received
- June 14, 2007
- Decision Date
- January 18, 2008
- Product Code
- DXG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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Other Clearances by Cheetah Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103166 | CHEETAH RELIANT | Jan 25, 2011 | Substantially Equivalent |
| K101487 | CHEETAH NICOM SYSTEM | Jul 2, 2010 | Substantially Equivalent |
| K083093 | CHEETAH RELIANT | Dec 15, 2008 | Substantially Equivalent |
| K072662 | CHEETAH RELIANT, CHEETAH ACTIVE | Jan 16, 2008 | Substantially Equivalent |
| K042144 | NICOM | Nov 12, 2004 | Substantially Equivalent |
| K023370 | CHEETAH I.V.D.S., MODEL 2002P | Dec 24, 2002 | Substantially Equivalent |