The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Wizard Series Cpap Mask.
Device ID | K103174 |
510k Number | K103174 |
Device Name: | APEX MEDICAL WIZARD SERIES CPAP MASK |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County, TW 236 |
Contact | Alan Chang |
Correspondent | Alan Chang APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County, TW 236 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-27 |
Decision Date | 2011-05-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04713025000752 | K103174 | 000 |
14713025000605 | K103174 | 000 |
04713025000592 | K103174 | 000 |
04713025000585 | K103174 | 000 |
14713025000575 | K103174 | 000 |
14713025000568 | K103174 | 000 |
14713025000551 | K103174 | 000 |
14713025000544 | K103174 | 000 |
04713025000530 | K103174 | 000 |
14713025000520 | K103174 | 000 |
14713025000636 | K103174 | 000 |
04713025000646 | K103174 | 000 |
04713025000653 | K103174 | 000 |
14713025000742 | K103174 | 000 |
04713025000738 | K103174 | 000 |
14713025000728 | K103174 | 000 |
04713025000714 | K103174 | 000 |
14713025000704 | K103174 | 000 |
04713025000691 | K103174 | 000 |
04713025000684 | K103174 | 000 |
04713025000677 | K103174 | 000 |
04713025000660 | K103174 | 000 |
14713025000513 | K103174 | 000 |