FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Intra.Ox 2.0 Handheld Tissue Oximeter
K Number: K191676
·
Decision Sep 16, 2019
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
73
Applicant Total
8
Review Days
84
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Basic Information
- Device Name
- Intra.Ox 2.0 Handheld Tissue Oximeter
- K Number
- K191676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vioptix, Inc.
- Date Received
- June 24, 2019
- Decision Date
- September 16, 2019
- Product Code
- MUD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | FDA class 2 | Cardiovascular |
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Other Clearances by Vioptix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | Feb 28, 2024 | Substantially Equivalent |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | May 3, 2022 | Substantially Equivalent |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Nov 16, 2017 | Substantially Equivalent |
| K133983 | INTRA. OX HANDHELD TISSUE OXIMETER | Sep 12, 2014 | Substantially Equivalent |
| K141234 | ODISSEY TISSUE OXIMETER | Jul 1, 2014 | Substantially Equivalent |
| K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM | Apr 17, 2009 | Substantially Equivalent |
| K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | Jan 10, 2005 | Substantially Equivalent |