FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EndoPATx
K Number: K211557
·
Decision Dec 29, 2022
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
403
Applicant Total
4
Review Days
589
Basic Information
- Device Name
- EndoPATx
- K Number
- K211557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Itamar Medical, Ltd.
- Date Received
- May 19, 2021
- Decision Date
- December 29, 2022
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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