The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Thera-mist(tm) Nebulizer, Model 30000.
| Device ID | K893942 |
| 510k Number | K893942 |
| Device Name: | THERA-MIST(TM) NEBULIZER, MODEL 30000 |
| 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 | 1989-05-31 |
| Decision Date | 1989-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 612223310110 | K893942 | 000 |
| 00612223030100 | K893942 | 000 |
| 00612223030124 | K893942 | 000 |
| 00612223030148 | K893942 | 000 |
| 00612223030315 | K893942 | 000 |
| 00612223030346 | K893942 | 000 |
| 612223300005 | K893942 | 000 |
| 612223300104 | K893942 | 000 |
| 612223300111 | K893942 | 000 |
| 612223300128 | K893942 | 000 |
| 00612223300357 | K893942 | 000 |
| 612223310103 | K893942 | 000 |
| 00612223700010 | K893942 | 000 |