FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EM ELECTRODE
K Number: K853774
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
23
Review Days
219
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Basic Information
- Device Name
- EM ELECTRODE
- K Number
- K853774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electromed Intl., Ltd.
- Date Received
- September 10, 1985
- Decision Date
- April 17, 1986
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Electromed Intl., Ltd.
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|---|---|---|---|
| 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 |
| K950694 | COMPACT-X | Mar 31, 1995 | 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 |