FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CKG 8000
K Number: K822020
·
Decision Aug 6, 1982
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- CKG 8000
- K Number
- K822020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardio Kinetics, Inc.
- Date Received
- July 9, 1982
- Decision Date
- August 6, 1982
- 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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