| Device Type ID | 890 |
| Device Name | Oximeter, Tissue Saturation |
| Regulation Description | Oximeter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MUD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 890 |
| Device | Oximeter, Tissue Saturation |
| Product Code | MUD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oximeter. |
| CFR Regulation Number | 870.2700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAS MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CHRISTIE MEDICAL HOLDINGS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAMAMATSU PHOTONICS K.K. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HYPERMED IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KENT IMAGING INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MASIMO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MESPERE LIFESCIENCES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MODULATED IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NONIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REFLECTANCE MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REFLECTANCE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIOPTIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIOPTIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Low Readings | 19 |
Incorrect Measurement | 11 |
High Readings | 7 |
Contamination / Decontamination Problem | 5 |
Device Operates Differently Than Expected | 4 |
False Reading From Device Non-Compliance | 3 |
Material Integrity Problem | 3 |
Sensing Intermittently | 3 |
Insufficient Information | 3 |
Device Stops Intermittently | 2 |
Device Sensing Problem | 1 |
Patient-Device Incompatibility | 1 |
Inappropriate Or Unexpected Reset | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Displays Incorrect Message | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 66 |