FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG MONITORING/DEFIBRILLATION ELECTRODE
K Number: K854433
·
Decision May 8, 1986
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
21
Review Days
184
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Basic Information
- Device Name
- ECG MONITORING/DEFIBRILLATION ELECTRODE
- K Number
- K854433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Andover Medical, Inc.
- Date Received
- November 5, 1985
- Decision Date
- May 8, 1986
- 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 |
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Other Clearances by Andover Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905729 | CANMED 451 | Feb 7, 1991 | Substantially Equivalent |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | Aug 17, 1990 | Substantially Equivalent |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | Jan 12, 1989 | Substantially Equivalent |
| K860636 | FASTRACE III, ECG ELECTRODE | May 9, 1986 | Substantially Equivalent |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Apr 1, 1986 | Substantially Equivalent |
| K860283 | AMI CARDIO-PAD | Mar 31, 1986 | Substantially Equivalent |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Nov 20, 1984 | Substantially Equivalent |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | Nov 20, 1984 | Substantially Equivalent |
| K843411 | THERMAL DILUTION CATHETER | Oct 18, 1984 | Substantially Equivalent |
| K843409 | FLOW-DIRECTED THERMODILUTION CATH | Oct 18, 1984 | Substantially Equivalent |