Photoplethysmograph Analysis Software For Over-the-counter Use
Device Code: 991
Product Code(s):
QDB Definition: A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis.
Device Classification Information
| Device Type ID | 991 |
| Device Name | Photoplethysmograph Analysis Software For Over-the-counter Use |
| Physical State | Software. |
| Technical Method | Analyzes Photoplethysmograph Data And Provides Detection Information. |
| Target Area | Software. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2790 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 991 |
| Device | Photoplethysmograph Analysis Software For Over-the-counter Use |
| Product Code | QDB |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 870.2790 [🔎] |
TPLC Last Update: 2019-04-02 19:45:57