The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Hope Continuous Nebulizer Model Hope-11310, Heart Nebulizer Model Heart-100609, Theramist Nebulizer Model Theramist-3100.
| Device ID | K122857 |
| 510k Number | K122857 |
| Device Name: | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 3303 HARBO BLVD SUITE F3 Costa Mesa, CA 92626 |
| Contact | Kenneth Miller |
| Correspondent | Kenneth Miller PEGASUS RESEARCH CORP. 3303 HARBO BLVD SUITE F3 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 | 2012-09-18 |
| Decision Date | 2012-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 612223310233 | K122857 | 000 |
| 00612223310196 | K122857 | 000 |
| 612223310134 | K122857 | 000 |
| 612223310127 | K122857 | 000 |