FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEETAH RELIANT
K Number: K083093
·
Decision Dec 15, 2008
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
110
Applicant Total
7
Review Days
59
Basic Information
- Device Name
- CHEETAH RELIANT
- K Number
- K083093
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CHEETAH MEDICAL INC.
- Date Received
- October 17, 2008
- Decision Date
- December 15, 2008
- Product Code
- DSB
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 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 |
| K071631 | NICOM ELECTRODES | Jan 18, 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 |