The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Minineb & Miniplus.
| Device ID | K050104 |
| 510k Number | K050104 |
| Device Name: | APEX MEDICAL MININEB & MINIPLUS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County, TW 236 |
| Contact | Anan Chang |
| Correspondent | Anan Chang APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County, TW 236 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411917971 | K050104 | 000 |
| 00607411007422 | K050104 | 000 |
| 10607411001250 | K050104 | 000 |