The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Autoclavable Version Thera-mist Nebulizer, P32000.
| Device ID | K914465 |
| 510k Number | K914465 |
| Device Name: | AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa, CA 92626 |
| Contact | Kenneth G Miller |
| Correspondent | Kenneth G Miller PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa, CA 92626 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1992-03-31 |