The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Mobineb, 9r-027 Series.
| Device ID | K070990 |
| 510k Number | K070990 |
| Device Name: | APEX MEDICAL MOBINEB, 9R-027 SERIES |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | APEX MEDICAL CORP. NO. 9, MINSHENG ST., TU-CHENG Taipei County, TW 236 |
| Contact | Alan Chang |
| Correspondent | Alan Chang APEX MEDICAL CORP. NO. 9, MINSHENG ST., TU-CHENG 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 | 2007-04-09 |
| Decision Date | 2007-05-18 |