FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFIGARD M(OR DEFISCOPE M
K Number: K823931
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
6
Review Days
104
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Basic Information
- Device Name
- DEFIGARD M(OR DEFISCOPE M
- K Number
- K823931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Odam
- Date Received
- December 29, 1982
- Decision Date
- April 12, 1983
- 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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Other Clearances by Odam
| K Number | Device Name | ||
|---|---|---|---|
| K972535 | MAGLIFE C | Jan 13, 1998 | Substantially Equivalent |
| K950264 | MAGLIFE | Sep 27, 1996 | Substantially Equivalent |
| K854175 | DEFIGARD 2000 | Jan 13, 1986 | Substantially Equivalent |
| K823934 | CARIEL F12 | Dec 16, 1983 | Substantially Equivalent |
| K823933 | MINIDEF (OR DEFIPORT | Apr 12, 1983 | Substantially Equivalent |