The following data is part of a premarket notification filed by Caradyne, Ltd. with the FDA for Guardian Neonate Cpap/humidification System.
| Device ID | K040862 |
| 510k Number | K040862 |
| Device Name: | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CARADYNE, LTD. PARKMORE BUSINESS PARK, PARKMORE WEST Galway, IE |
| Contact | John O'dea |
| Correspondent | John O'dea CARADYNE, LTD. PARKMORE BUSINESS PARK, PARKMORE WEST Galway, IE |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-06-30 |
| Summary: | summary |