The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Bestneb Portable Aerosol Therapy Unit, Ap-100100.
| Device ID | K990435 |
| 510k Number | K990435 |
| Device Name: | BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Contact | Daniel Lee |
| Correspondent | Daniel Lee APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-11 |
| Decision Date | 2000-06-05 |