FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
K Number: K864260
·
Decision May 11, 1987
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
8
Review Days
194
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Basic Information
- Device Name
- APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
- K Number
- K864260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Grandcor Medical Systems
- Date Received
- October 29, 1986
- Decision Date
- May 11, 1987
- 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 Grandcor Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K905480 | SPIROSCOPE | May 6, 1991 | Substantially Equivalent |
| K895547 | GRANDCOR/CARDIOLINE ECT STRESS TESTING | Mar 13, 1990 | Substantially Equivalent |
| K883410 | CARDIOMEGA-T | Oct 17, 1988 | Substantially Equivalent |
| K871890 | CARDIO-MEGA SYSTEM | Jun 12, 1987 | Substantially Equivalent |
| K864978 | APPLISCOPE | Feb 19, 1987 | Substantially Equivalent |
| K864581 | APPLIDYN | Jan 21, 1987 | Substantially Equivalent |
| K862375 | CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM | Jul 1, 1986 | Substantially Equivalent |