The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Thera-mist Humidifier.
| Device ID | K894000 |
| 510k Number | K894000 |
| Device Name: | THERA-MIST HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa, CA 92626 |
| Contact | Kenneth Miller |
| Correspondent | Kenneth Miller 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 | 1989-06-05 |
| Decision Date | 1989-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 612223035006 | K894000 | 000 |
| 00612223013103 | K894000 | 000 |
| 00612223001339 | K894000 | 000 |
| 00612223001315 | K894000 | 000 |