FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMPUMED DICON CLIENT
K Number: K955708
·
Decision Mar 1, 1996
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
6
Review Days
78
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Basic Information
- Device Name
- COMPUMED DICON CLIENT
- K Number
- K955708
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compumed, Inc.
- Date Received
- December 14, 1995
- Decision Date
- March 1, 1996
- Product Code
- LMD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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|---|---|---|---|
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| K802272 | COMPUTER ECG TERMINAL | Sep 26, 1980 | Substantially Equivalent |
| K771648 | COMPUTER ECG TERMINAL | Sep 20, 1977 | Substantially Equivalent |