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 |