Definition: Same As DQA Except Reprocessed
| Device Type ID | 212 |
| Device Name | Oximeter, Reprocessed |
| Regulation Description | Oximeter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NLF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 212 |
| Device | Oximeter, Reprocessed |
| Product Code | NLF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oximeter. |
| CFR Regulation Number | 870.2700 [🔎] |
| Device Problems | |
|---|---|
Fracture | 33 |
Insufficient Information | 20 |
Crack | 11 |
Metal Shedding Debris | 7 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Migration Or Expulsion Of Device | 3 |
Device Inoperable | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Detachment Of Device Component | 1 |
Peeled / Delaminated | 1 |
No Device Output | 1 |
Naturally Worn | 1 |
Noise, Audible | 1 |
Sensor | 1 |
Material Erosion | 1 |
Difficult To Insert | 1 |
Device Damaged Prior To Use | 1 |
Device Dislodged Or Dislocated | 1 |
Appropriate Term/Code Not Available | 1 |
Incorrect Measurement | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
| Total Device Problems | 98 |