The following data is part of a premarket notification filed by Newport Biosystems, Inc. with the FDA for Transfer Container Humidifier.
| Device ID | K881648 |
| 510k Number | K881648 |
| Device Name: | TRANSFER CONTAINER HUMIDIFIER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | NEWPORT BIOSYSTEMS, INC. 2480 MIDDLEFIELD RD. #2007 Redwood City, CA 94063 |
| Contact | Rod Roberts |
| Correspondent | Rod Roberts NEWPORT BIOSYSTEMS, INC. 2480 MIDDLEFIELD RD. #2007 Redwood City, CA 94063 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-15 |
| Decision Date | 1988-12-30 |