FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K Number: K112376
·
Decision Aug 31, 2011
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
1
Review Days
14
Basic Information
- Device Name
- S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
- K Number
- K112376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CIRCA SCIENTIFIC, LLC
- Date Received
- August 17, 2011
- Decision Date
- August 31, 2011
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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