FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EnsoETM
K Number: K172493
·
Decision Oct 17, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
2
Review Days
60
Basic Information
- Device Name
- EnsoETM
- K Number
- K172493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Attune Medical
- Date Received
- August 18, 2017
- Decision Date
- October 17, 2017
- Product Code
- PLA
- 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 |
|---|---|---|---|
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device | FDA class 2 | Cardiovascular |
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Other Clearances by Attune Medical
| K Number | Device Name | ||
|---|---|---|---|
| K172029 | EnsoETM | Jan 5, 2018 | Substantially Equivalent |