FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASI LEAD SYSTEM CABLE ASSEMBLY
K Number: K872781
·
Decision Dec 29, 1987
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
7
Applicant Total
2
Review Days
168
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Basic Information
- Device Name
- EASI LEAD SYSTEM CABLE ASSEMBLY
- K Number
- K872781
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Totemite Medical Electronics
- Date Received
- July 14, 1987
- Decision Date
- December 29, 1987
- Product Code
- DRW
- 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 |
|---|---|---|---|
| DRW | Adaptor, Lead Switching, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Totemite Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K802900 | HEART SENTINEL | Mar 11, 1981 | Substantially Equivalent |