FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
K Number: K012218
·
Decision Oct 12, 2001
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
3
Review Days
88
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Basic Information
- Device Name
- LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
- K Number
- K012218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Ludlow Company LP
- Date Received
- July 16, 2001
- Decision Date
- October 12, 2001
- Product Code
- DRO
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
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