Austin, TX, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MPO | — | — | — | 1 | 2022-10-07 |
| IMD | Pack, Hot Or Cold, Disposable | Class I | Physical Medicine | 1 | 2022-10-06 |
| FPL | Incubator, Neonatal Transport | Class II | General Hospital | 1 | 2022-07-15 |
| MRN | — | — | — | 1 | 2020-03-10 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2022-10-07 | K221154 | Infant Heel WarmerTM; Heel Snuggler® | MPO | — | — |
| 2022-10-06 | K221653 | InfaTherm Disposable Infant Warming Mattress | IMD | Class I | Physical Medicine |
| 2022-07-15 | K220742 | NxtGen Infant Transport Incubator | FPL | Class II | General Hospital |
| 2020-03-10 | K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | MRN | — | — |