FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINI-DEFIBRILLATOR 280/4
K Number: K840246
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
20
Review Days
96
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Basic Information
- Device Name
- MINI-DEFIBRILLATOR 280/4
- K Number
- K840246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Science Instrumentation, Inc.
- Date Received
- January 12, 1984
- Decision Date
- April 17, 1984
- 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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| K822389 | LIFE TRACE 40/42 | Sep 21, 1982 | Substantially Equivalent |
| K822294 | VPD-261 DEFIBRILLATOR MONITOR | Aug 31, 1982 | Substantially Equivalent |