FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
K Number: K120815
·
Decision Mar 6, 2013
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
107
Review Days
352
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Basic Information
- Device Name
- INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
- K Number
- K120815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems
- Date Received
- March 19, 2012
- Decision Date
- March 6, 2013
- Product Code
- FPD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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