FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIONEER II BACK PLATE ELECTRODE
K Number: K820122
·
Decision Mar 1, 1982
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
20
Review Days
42
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
- PIONEER II BACK PLATE ELECTRODE
- K Number
- K820122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Science Instrumentation, Inc.
- Date Received
- January 18, 1982
- Decision Date
- March 1, 1982
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRX), ordered by most recent decision date.
Physiotrace
FDA 510(k)
FDA Class 2
·Cardiovascular
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMODULE 3-M1
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
IP-SET
FDA 510(k)
FDA Class 2
·Cardiovascular
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Life Science Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850812 | EMERGIPACE - EXTERNAL PACEMAKER | Nov 5, 1985 | Substantially Equivalent |
| 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 |