The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Xt1 Cpap, Model 9s-005.
Device ID | K070609 |
510k Number | K070609 |
Device Name: | APEX MEDICAL XT1 CPAP, MODEL 9S-005 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-05 |
Decision Date | 2007-05-04 |