The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Arabella Ncpap Masks.
| Device ID | K030563 |
| 510k Number | K030563 |
| Device Name: | ARABELLA NCPAP MASKS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HAMILTON MEDICAL AG PO BOX 30008 Reno, NV 89502 |
| Contact | J. David Thompson |
| Correspondent | J. David Thompson HAMILTON MEDICAL AG PO BOX 30008 Reno, NV 89502 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-21 |
| Decision Date | 2003-09-09 |
| Summary: | summary |