The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Autoclavable Thera-mist Humidifier P3600, Modified.
| Device ID | K915890 |
| 510k Number | K915890 |
| Device Name: | AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa, CA 92626 |
| Contact | William Burke |
| Correspondent | William Burke PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa, CA 92626 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-06-24 |