Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Microphone for Snoring detection SOMNO HD | NGS130 | SOMNOmedics AG | MNR | 04250413410057 |
| Fingerclip Small - Soft Silicone | NGS301 | SOMNOmedics AG | MNR | 04250413405695 |
| SOMNOscreen ECO EEG 32 | NGN740U | SOMNOmedics AG | MNR | 04250413410828 |
| Inductive Effort Belts - Size S | SEN660 | SOMNOmedics AG | MNR | 04250413404247 |
| Inductive Effort Belts - Size M | SEN661 | SOMNOmedics AG | MNR | 04250413404254 |
| SpO2 Soft Silicone Finger Clip | SEWP150 | SOMNOmedics AG | MNR | 04250413401796 |
| PLM sensor left for SOMNO HD Cable length 120 cm | NGS070 | SOMNOmedics AG | MNR | 04250413410026 |
| 1-channel analogue optocoupler | NGA100 | SOMNOmedics AG | MNR | 04250413410095 |
| Inductive Effort Belts - Size XXL | SEN663 | SOMNOmedics AG | MNR | 04250413404278 |
| Set for wireless PLM measurement | NGA113 | SOMNOmedics AG | MNR | 04250413410705 |
| Inductive Effort Belt - size L | NGA202 | SOMNOmedics AG | MNR | 04250413410125 |
| 1 channel ECG sensor | NGS090 | SOMNOmedics AG | MNR | 04250413410040 |
| SLP Thermistor LOW COST | SEN600S | SOMNOmedics AG | MNR | 04250413402267 |
| Effort Sensor | SEN640 | SOMNOmedics AG | MNR | 04250413400461 |
| 1 channel ECG sensor including body position and disposable electrodes | NGS091S | SOMNOmedics AG | MNR | 04250413410712 |
| Miniaturized Pneumotachograph Set | SEN513 | SOMNOmedics AG | 04250413402250 | |
| Inductive Effort Belt - size S | NGA200 | SOMNOmedics AG | MNR | 04250413410101 |
| Belt Set - Size L | SEN234 | SOMNOmedics AG | MNR | 04250413401031 |
| Nasal/Oral flow sensor thermistor adult | NGS151 | SOMNOmedics AG | MNR | 04250413410071 |
| Abdomen/Thorax Belt - Size XXL | SEN228 | SOMNOmedics AG | MNR | 04250413401086 |
| Abdomen/Thorax Belt - Size S | SEN238 | SOMNOmedics AG | MNR | 04250413401055 |
| Adapter for thermistor for SOMNO HD | NGS150 | SOMNOmedics AG | MNR | 04250413410064 |
| 1-channel ECG Electrode | SEN627 | SOMNOmedics AG | MNR | 04250413400416 |
| SOMNOscreen plus EEG32 | SEN043 | SOMNOmedics AG | MNR | 04250413402021 |
| Digital PSG Head Box for SOMNO HD | NGS901 | SOMNOmedics AG | MNR | 04250413410088 |