FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EndoPATx
K Number: K211557
·
Decision Dec 29, 2022
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
11
Review Days
589
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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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Other Clearances by Itamar Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250460 | WatchPAT400 (WP400) | Sep 5, 2025 | Substantially Equivalent |
| K223675 | WatchPAT ONE (WP1) | Jan 6, 2023 | Substantially Equivalent |
| K222331 | WatchPAT300 (WP300) | Sep 14, 2022 | Substantially Equivalent |
| K203839 | WatchPAT200U (WP200U) | Mar 21, 2022 | Substantially Equivalent |
| K183559 | WatchPAT ONE | Jun 5, 2019 | Substantially Equivalent |
| K180775 | Watch-PAT300 | Aug 17, 2018 | Substantially Equivalent |
| K161579 | Watch-PAT200U | Feb 24, 2017 | Substantially Equivalent |
| K153070 | Watch-PAT200U | Jul 26, 2016 | Substantially Equivalent |
| K133859 | WATCH-PAT200U (WP200U) | May 30, 2014 | Substantially Equivalent |
| K102567 | WATCH-PAT 200S-3 (WP200S-3) | Jun 2, 2011 | Substantially Equivalent |