FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
PORTABLE INSTENSIVE CARE UNIT
K Number: K010207
·
Decision Jun 14, 2001
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
227
Applicant Total
19
Review Days
142
Basic Information
- Device Name
- PORTABLE INSTENSIVE CARE UNIT
- K Number
- K010207
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- MEDICAL RESEARCH LABORATORIES, INC.
- Date Received
- January 23, 2001
- Decision Date
- June 14, 2001
- Product Code
- MKJ
- 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | 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 |
| 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 |
| K952085 | DPD DEFIBRILLATOR | Jun 5, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K935922 | 360 SLX ADVISORY DEFIBRILLATOR | Dec 22, 1994 | Substantially Equivalent |
| K930548 | DPD DEFIBRILLATOR | Jun 25, 1993 | Substantially Equivalent |