FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
OptoMonitor 3
K Number: K193620
·
Decision Jun 18, 2020
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
10
Review Days
175
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Basic Information
- Device Name
- OptoMonitor 3
- K Number
- K193620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Opsens, Inc.
- Date Received
- December 26, 2019
- Decision Date
- June 18, 2020
- Product Code
- DXO
- 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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
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Other Clearances by Opsens, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251367 | OptoMonitor 3 | Jan 16, 2026 | Substantially Equivalent |
| K241418 | OptoMonitor 3 | Feb 12, 2025 | Substantially Equivalent |
| K240864 | PacePro Wire | May 24, 2024 | Substantially Equivalent |
| K213854 | SavvyWire | Sep 14, 2022 | Substantially Equivalent |
| K202943 | OptoMonitor 3 | Nov 24, 2020 | Substantially Equivalent |
| K191907 | OptoWire III | Jan 2, 2020 | Substantially Equivalent |
| K192340 | OptoMonitor | Dec 12, 2019 | Substantially Equivalent |
| K161263 | OptoMonitor II | Sep 13, 2016 | Substantially Equivalent |
| K142598 | Opto Wire and OptoMonitor System | Jun 12, 2015 | Substantially Equivalent |