FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K Number: K875059
·
Decision Feb 12, 1988
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
63
Review Days
65
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Basic Information
- Device Name
- DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
- K Number
- K875059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Daig Corp.
- Date Received
- December 9, 1987
- Decision Date
- February 12, 1988
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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