FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHYSIOLOG, SERIES 95000
K Number: K013032
·
Decision Jun 4, 2002
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
16
Review Days
267
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Basic Information
- Device Name
- PHYSIOLOG, SERIES 95000
- K Number
- K013032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Camtronics, Ltd.
- Date Received
- September 10, 2001
- Decision Date
- June 4, 2002
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Camtronics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K021236 | SURGERY AND ACCESSORIES | Jul 17, 2002 | Substantially Equivalent |
| K992666 | VIDEO PLUS SYSTEM, SERIES 95000 | Oct 13, 1999 | Substantially Equivalent |
| K992259 | ECHOCARDIOGRAPHY SYSTEM SERIES 95000 | Sep 8, 1999 | Substantially Equivalent |
| K990066 | CCD CAMERA, MODEL 9000 | Mar 17, 1999 | Substantially Equivalent |
| K955519 | ANALYTICAL REVIEW STATION | May 9, 1996 | Substantially Equivalent |
| K954159 | DIGITAL IMAGING SYSTEM | Mar 19, 1996 | Substantially Equivalent |
| K955232 | NT SERIES DIGITAL IMAGE MANAGER | Dec 11, 1995 | Substantially Equivalent |
| K953080 | DIGITAL IMAGING SYSTEM INTERFACE | Sep 28, 1995 | Substantially Equivalent |
| K945654 | NICOM DIGITAL IMAGE MANAGER | Feb 17, 1995 | Substantially Equivalent |
| K941979 | VIDEO PLUS WITH ANALYTICAL WORKSTATION | Aug 17, 1994 | Substantially Equivalent |