The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Thera-mist Tm Volumina Incent Spirometer, P40000.
| Device ID | K903489 |
| 510k Number | K903489 |
| Device Name: | THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 |
| Classification | Spirometer, Therapeutic (incentive) |
| 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 | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-02 |
| Decision Date | 1990-12-10 |