FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
450SLL DEFIBRILLATOR
K Number: K874204
·
Decision Jan 28, 1988
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
19
Review Days
105
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 450SLL DEFIBRILLATOR
- K Number
- K874204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Research Laboratories, Inc.
- Date Received
- October 15, 1987
- Decision Date
- January 28, 1988
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDD), ordered by most recent decision date.
Switched Internal Paddles
FDA 510(k)
FDA Class 2
·Cardiovascular
Tempus LS - Manual
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Rapid Hair Removal Pads
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOLL E SERIES ALS
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOMED
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K952085 | DPD DEFIBRILLATOR | Jun 5, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K935922 | 360 SLX ADVISORY DEFIBRILLATOR | Dec 22, 1994 | Substantially Equivalent |