FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOAH MONITORING ELECTRODE SYSTEM
K Number: K970125
·
Decision Mar 4, 1997
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
9
Review Days
49
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Basic Information
- Device Name
- NOAH MONITORING ELECTRODE SYSTEM
- K Number
- K970125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Contour Medical Technology, Inc.
- Date Received
- January 14, 1997
- Decision Date
- March 4, 1997
- 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 Contour Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970391 | QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES | Mar 6, 1997 | Substantially Equivalent |
| K960329 | DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD | Jul 2, 1996 | Substantially Equivalent |
| K952805 | TEMPERATURE PROBE-TP550 | Apr 4, 1996 | Substantially Equivalent |
| K952807 | TEMPERATURE PROBE-TP650 | Apr 4, 1996 | Substantially Equivalent |
| K952801 | TEMPERATURE PROBE-TP250 | Apr 4, 1996 | Substantially Equivalent |
| K952800 | TEMPERATURE PROBE-TP150 | Apr 4, 1996 | Substantially Equivalent |
| K952803 | TEMPERATURE PROBE-TP350 | Apr 4, 1996 | Substantially Equivalent |
| K952804 | TEMPERATURE PROBE-TP450 | Apr 4, 1996 | Substantially Equivalent |