FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES
K Number: K935246
·
Decision Nov 16, 1994
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
15
Review Days
380
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Basic Information
- Device Name
- ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES
- K Number
- K935246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Arbo Medical, Inc.
- Date Received
- November 1, 1993
- Decision Date
- November 16, 1994
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K935437 | ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES | Apr 6, 1995 | Substantially Equivalent |
| K942905 | DISPOSABLE TEMPERATURE PROBE COVER | Feb 27, 1995 | Substantially Equivalent |
| K940302 | ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM | Nov 30, 1994 | Substantially Equivalent |
| K940322 | ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE | Nov 28, 1994 | Substantially Equivalent |
| K935429 | ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES | Nov 1, 1994 | Substantially Equivalent |
| K935281 | ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES | Sep 6, 1994 | Substantially Equivalent |
| K905545 | ULTRASOUND TRANSMISSION GEL | Mar 29, 1991 | Substantially Equivalent |
| K902788 | CLEM TM | Sep 12, 1990 | Substantially Equivalent |
| K901816 | PRESSURE TUBING AND ACCESSORIES | Jul 12, 1990 | Substantially Equivalent |