FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
DPD DEFIBRILLATOR
K Number: K952085
·
Decision Jun 5, 1995
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
165
Applicant Total
19
Review Days
33
Basic Information
- Device Name
- DPD DEFIBRILLATOR
- K Number
- K952085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- MEDICAL RESEARCH LABORATORIES, INC.
- Date Received
- May 3, 1995
- Decision Date
- June 5, 1995
- 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 MEDICAL RESEARCH LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K021168 | JUMP START, MODEL 970300 | Jun 26, 2002 | Substantially Equivalent - Subject to Tracking Reg. |
| K012766 | PORTABLE INTENSIVE CARE UNIT | Jan 23, 2002 | Substantially Equivalent - Subject to Tracking Reg. |
| K012030 | PORTABLE INTENSIVE CARE UNIT | Sep 24, 2001 | Substantially Equivalent |
| K010207 | PORTABLE INSTENSIVE CARE UNIT | Jun 14, 2001 | Substantially Equivalent - Subject to Tracking Reg. |
| K002232 | AEDEFIBRILLATOR | Dec 6, 2000 | Substantially Equivalent |
| K000712 | PORTABLE INTENSIVE CARE UNIT, MODEL PIC | Apr 27, 2000 | Substantially Equivalent |
| K983307 | MODIFICATION TO PORTABLE INTENSIVE CARE UNIT | Nov 20, 1998 | Substantially Equivalent |
| K974034 | PORTABLE INTENSIVE CARE UNIT | Mar 2, 1998 | Substantially Equivalent |
| K935922 | 360 SLX ADVISORY DEFIBRILLATOR | Dec 22, 1994 | Substantially Equivalent |
| K930548 | DPD DEFIBRILLATOR | Jun 25, 1993 | Substantially Equivalent |