The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Pmh 5000 Heated Humidifier For Respiratory Therapy.
| Device ID | K020700 |
| 510k Number | K020700 |
| Device Name: | PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 1714 SOUTH LYON ST. Santa Ana, CA 92705 |
| Contact | Kenneth G Miller |
| Correspondent | Kenneth G Miller PEGASUS RESEARCH CORP. 1714 SOUTH LYON ST. Santa Ana, CA 92705 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2004-04-26 |