The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Aero-mist Nebulizer Heater.
| Device ID | K880473 |
| 510k Number | K880473 |
| Device Name: | AERO-MIST NEBULIZER HEATER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 3334 E. COAST HIGHWAY, SUITE 297 Corona Del Mar, CA 92625 |
| Contact | Kenneth G Miller |
| Correspondent | Kenneth G Miller PEGASUS RESEARCH CORP. 3334 E. COAST HIGHWAY, SUITE 297 Corona Del Mar, CA 92625 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612223200114 | K880473 | 000 |
| 00612223230005 | K880473 | 000 |
| 00612223230012 | K880473 | 000 |
| 00612223260002 | K880473 | 000 |
| 00612223260019 | K880473 | 000 |
| 00612223260026 | K880473 | 000 |
| 00612223261009 | K880473 | 000 |
| 00612223261016 | K880473 | 000 |
| 00612223262006 | K880473 | 000 |
| 00612223200121 | K880473 | 000 |
| 14026704663887 | K880473 | 000 |
| 00612223020002 | K880473 | 000 |
| 00612223057053 | K880473 | 000 |
| 00612223200015 | K880473 | 000 |
| 00612223701000 | K880473 | 000 |