FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPERATURE PROBE-TP550
K Number: K952805
·
Decision Apr 4, 1996
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
9
Review Days
290
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Basic Information
- Device Name
- TEMPERATURE PROBE-TP550
- K Number
- K952805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Contour Medical Technology, Inc.
- Date Received
- June 19, 1995
- Decision Date
- April 4, 1996
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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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 |
| K970125 | NOAH MONITORING ELECTRODE SYSTEM | Mar 4, 1997 | Substantially Equivalent |
| K960329 | DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD | Jul 2, 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 |