DEN220091 is an FDA 510(k) submission for the Dream Sock. This device is classified as a Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use (Class II - Special Controls, product code QYU).
Submitted by Owlet Babycare, Inc. (Lehi, US). The FDA issued a Not Cleared (DENG) decision on November 8, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2705. An Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use Is A Device That Uses Photoplethysmography To Measure Pulse Rate And Oxygen Saturation In Infants. The Device May Contain Alarms That Alert The Caregiver When Vital Sign(s) Go Outside Preset Threshold(s)..
| 510(k) Number | DEN220091 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 14, 2022 |
| Decision Date | November 08, 2023 |
| Days to Decision | 329 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QYU - Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2705 |
| Definition | An Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use Is A Device That Uses Photoplethysmography To Measure Pulse Rate And Oxygen Saturation In Infants. The Device May Contain Alarms That Alert The Caregiver When Vital Sign(s) Go Outside Preset Threshold(s). |