FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYBER DX 100
K Number: K791229
·
Decision Jul 30, 1979
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
1
Review Days
21
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Basic Information
- Device Name
- CYBER DX 100
- K Number
- K791229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1900
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cyber Diagnostics
- Date Received
- July 9, 1979
- Decision Date
- July 30, 1979
- Product Code
- BZM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | FDA class 2 | Anesthesiology |
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