The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Thera-mist Nebulizer Model-p3000.
| Device ID | K962534 |
| 510k Number | K962534 |
| Device Name: | THERA-MIST NEBULIZER MODEL-P3000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PEGASUS RESEARCH CORP. 2003 SOUTH RITCHEY AVE. Santa Ana, CA 92705 |
| Contact | Michael Hennigman |
| Correspondent | Michael Hennigman PEGASUS RESEARCH CORP. 2003 SOUTH RITCHEY AVE. Santa Ana, CA 92705 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1997-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 612223310226 | K962534 | 000 |
| 00612223030254 | K962534 | 000 |
| 00612223030278 | K962534 | 000 |
| 00612223030322 | K962534 | 000 |
| 612223030216 | K962534 | 000 |
| 00612223300258 | K962534 | 000 |
| 612223300210 | K962534 | 000 |
| 612223300227 | K962534 | 000 |
| 612223300234 | K962534 | 000 |
| 00612223300296 | K962534 | 000 |
| 612223300319 | K962534 | 000 |
| 00612223310257 | K962534 | 000 |
| 00612223310264 | K962534 | 000 |
| 00612223030230 | K962534 | 000 |