The following data is part of a premarket notification filed by Human Design Medical, Llc with the FDA for Z1 Cpap System.
| Device ID | K140929 |
| 510k Number | K140929 |
| Device Name: | Z1 CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HUMAN DESIGN MEDICAL, LLC 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell HUMAN DESIGN MEDICAL, LLC 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-09 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859477004161 | K140929 | 000 |
| 00859477004123 | K140929 | 000 |