FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
K Number: K011734
·
Decision Jul 3, 2001
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
- K Number
- K011734
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mogul Enterprises
- Date Received
- June 5, 2001
- Decision Date
- July 3, 2001
- Product Code
- DRF
- 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |
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