The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Ventstar Heated, Infinity Id Breathing Circuit Heated.
| Device ID | K102618 |
| 510k Number | K102618 |
| Device Name: | VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-13 |
| Decision Date | 2010-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675253372 | K102618 | 000 |
| 04048675253365 | K102618 | 000 |
| 04048675253358 | K102618 | 000 |
| 04048675422464 | K102618 | 000 |