FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTA-FIB LPD
K Number: K801544
·
Decision Jul 14, 1980
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
9
Review Days
7
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Basic Information
- Device Name
- PORTA-FIB LPD
- K Number
- K801544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Narco Bio-Systems
- Date Received
- July 7, 1980
- Decision Date
- July 14, 1980
- Product Code
- LDD
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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| K760084 | MONITOR, GSR (NB-401) | Jul 26, 1976 | Substantially Equivalent |
| K760083 | PHYSIOSCOPE | Jul 20, 1976 | Substantially Equivalent |