FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINICAL DATA SYSTEM (CAM) MODULE
K Number: K801029
·
Decision May 28, 1980
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
80
Applicant Total
88
Review Days
27
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Basic Information
- Device Name
- CLINICAL DATA SYSTEM (CAM) MODULE
- K Number
- K801029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4635
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Adac Laboratories
- Date Received
- May 1, 1980
- Decision Date
- May 28, 1980
- Product Code
- LEJ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LEJ | Booth, Sun Tan | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K042880 | JETSTREAM WORKSPACE | Nov 3, 2004 | Substantially Equivalent |
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| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Jun 25, 2004 | Substantially Equivalent |
| K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM | May 24, 2004 | Substantially Equivalent |
| K041182 | SYNTEGRA | May 21, 2004 | Substantially Equivalent |
| K040326 | AUTOQUANT PLUS | Feb 25, 2004 | Substantially Equivalent |