FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMERGIPACE - EXTERNAL PACEMAKER
K Number: K850812
·
Decision Nov 5, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
20
Review Days
250
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
- EMERGIPACE - EXTERNAL PACEMAKER
- K Number
- K850812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Science Instrumentation, Inc.
- Date Received
- February 28, 1985
- Decision Date
- November 5, 1985
- Product Code
- DRO
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRO), ordered by most recent decision date.
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
FDA 510(k)
FDA Class 2
·Cardiovascular
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
FDA 510(k)
FDA Class 2
·Cardiovascular
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
FDA 510(k)
FDA Class 2
·Cardiovascular
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE INTENSIVE CARE UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Life Science Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842037 | LS 5 | Mar 1, 1985 | Substantially Equivalent |
| K843396 | LS-260G MONITOR/RECORDER & DEFIBILLATOR | Oct 19, 1984 | Substantially Equivalent |
| K840246 | MINI-DEFIBRILLATOR 280/4 | Apr 17, 1984 | Substantially Equivalent |
| K831056 | DEFIBRILLATOR VPD 545 | Apr 28, 1983 | Substantially Equivalent |
| K822617 | VPD540 DEFIBRILLATOR | Apr 28, 1983 | Substantially Equivalent |
| K822616 | LS6 ARRYTHMIA DISCRIMINATOR | Oct 18, 1982 | Substantially Equivalent |
| K822390 | LIFE TRACE 24 | Sep 21, 1982 | Substantially Equivalent |
| K822615 | LIFE WATCH LSI | Sep 21, 1982 | Substantially Equivalent |
| K822389 | LIFE TRACE 40/42 | Sep 21, 1982 | Substantially Equivalent |
| K822294 | VPD-261 DEFIBRILLATOR MONITOR | Aug 31, 1982 | Substantially Equivalent |