The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Xt Auto Cpap With Compliance Improvement Algorithm 9s-005720.
| Device ID | K112079 |
| 510k Number | K112079 |
| Device Name: | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 |
| 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 | 2011-07-21 |
| Decision Date | 2012-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14713025000070 | K112079 | 000 |
| 14713025000056 | K112079 | 000 |
| 04713025000035 | K112079 | 000 |
| 04713025000011 | K112079 | 000 |