FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMD HOME HEALTH MONITORING SYSTEM
K Number: K960337
·
Decision Sep 24, 1996
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
2
Review Days
244
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Basic Information
- Device Name
- AMD HOME HEALTH MONITORING SYSTEM
- K Number
- K960337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Medical Devices, Inc.
- Date Received
- January 24, 1996
- Decision Date
- September 24, 1996
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Advanced Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982793 | PIEZO TRONIC | Oct 28, 1998 | Substantially Equivalent |