The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for H2 Heated Humidifier.
| Device ID | K030090 |
| 510k Number | K030090 |
| Device Name: | H2 HEATED HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-10 |
| Decision Date | 2003-01-24 |
| Summary: | summary |