FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EnsoETM
K Number: K172029
·
Decision Jan 5, 2018
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
2
Review Days
184
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Basic Information
- Device Name
- EnsoETM
- K Number
- K172029
- 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
- July 5, 2017
- Decision Date
- January 5, 2018
- 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 | ||
|---|---|---|---|
| K172493 | EnsoETM | Oct 17, 2017 | Substantially Equivalent |