The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-h900, Hamilton-bc8022, Hamilton-bc4022, Hamilton-bc8010, Hamilton-bc4010.
| Device ID | K152029 |
| 510k Number | K152029 |
| Device Name: | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH 7402 |
| Contact | Steffen Boden |
| Correspondent | Steffen Boden HAMILTON MEDICAL AG VIA CRUSCH 8 Bonaduz, CH 7402 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2016-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630002804189 | K152029 | 000 |
| 07630002801560 | K152029 | 000 |
| 07630002801546 | K152029 | 000 |
| 07630002801416 | K152029 | 000 |
| 07630002800846 | K152029 | 000 |