FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
COMPACT-X
K Number: K950694
·
Decision Mar 31, 1995
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
23
Review Days
45
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Basic Information
- Device Name
- COMPACT-X
- K Number
- K950694
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electromed Intl., Ltd.
- Date Received
- February 14, 1995
- Decision Date
- March 31, 1995
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Electromed Intl., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K003688 | VIEW READING STATION | Jan 22, 2001 | Substantially Equivalent |
| K000474 | VIEW NT | Apr 19, 2000 | Substantially Equivalent |
| K990759 | VIEW COM | Apr 15, 1999 | Substantially Equivalent |
| K974255 | CD-R STATION AND VRS-2000 | Jan 27, 1998 | Substantially Equivalent |
| K971176 | VIEW ARCHIVING STATION | Sep 3, 1997 | Substantially Equivalent |
| K880050 | EDEC 60R | Feb 29, 1988 | Substantially Equivalent |
| K875341 | EDEC 60 R/F | Feb 1, 1988 | Substantially Equivalent |
| K875342 | EDEC 90C | Jan 29, 1988 | Substantially Equivalent |
| K871145 | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR | Mar 31, 1987 | Substantially Equivalent |
| K870851 | EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR | Mar 20, 1987 | Substantially Equivalent |