Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Alice PDx | Alice PDx Core System without Sensors, US | Respironics, Inc. | MNR | 00606959039018 |
| Alice PDx | Alice PDx Sleep Diagnostic System, INTL | Respironics, Inc. | MNR | 00606959020481 |
| Alice PDx | Alice PDx Sleep Diagnostic System, CN | Respironics, Inc. | MNR | 00606959038837 |
| Alice PDx | Alice PDx Unit Only, Warranty Replacement, US | Respironics, Inc. | MNR | 00606959038974 |
| Alice PDx | Alice PDx ECG Yoke, INTL | Respironics, Inc. | MNR | 00606959020450 |
| AlicePDx | Alice PDx MobileLink Cable | Respironics, Inc. | MNR | 00606959049710 |
| Alice PDx | Alice PDx ECG Yoke, US | Respironics, Inc. | MNR | 00606959033573 |
| Alice PDX Assembly, JP | JAPAN | Respironics, Inc. | MNR | 00606959060401 |
| ALICE PDx | Alice PDx Sleep Diagnostic System, JP | Respironics, Inc. | MNR | 00606959038813 |
| ALICE PDx | Alice PDx Sleep Diagnostic System, US | Respironics, Inc. | MNR | 00606959003835 |
| Alice PDx | Alice PDx ExG Yoke, US | Respironics, Inc. | MNR | 00606959033566 |
| Alice PDx | Alice PDx Unit Only, Warranty Exchange, INTL | Respironics, Inc. | MNR | 00606959020689 |
| Alice PDx | Alice PDx ExG Yoke, INTL | Respironics, Inc. | MNR | 00606959020559 |
| Alice PDx | Alice PDx Core System without Sensors, JP | Respironics, Inc. | MNR | 00606959039032 |
| Alice PDx | Alice PDx Core System without Sensors, INTL | Respironics, Inc. | MNR | 00606959039025 |
| ALICE PDX Assembly, BR | BRAZIL | Respironics, Inc. | MNR | 00606959060418 |
| Sensor | CPAP TITRATION KIT, ALICE PDx | Respironics, Inc. | MNR | 00606959009790 |
| Alice PDx | Alice PDx ECG Yoke, JP | Respironics, Inc. | MNR | 00606959033580 |
| ALICE PDX Assembly, INTL | INTERNATIONAL | Respironics, Inc. | MNR | 00606959060395 |
| ALICE PDX Assembly, DOM | DOMESTIC | Respironics, Inc. | MNR | 00606959060388 |
| Alice PDx | Alice PDx Unit Only, Warranty Exchange, JP | Respironics, Inc. | MNR | 00606959038981 |
| Alice PDx | Alice PDx Sleep Diagnostic System, BR | Respironics, Inc. | MNR | 00606959038820 |