The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Corp. Ich Cpap With Pva 9s-007xxx Series.
| Device ID | K141522 |
| 510k Number | K141522 |
| Device Name: | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | APEX MEDICAL CORP. NO. 9, MIN SHENG ST., TU-CHENG, New Taipei City, TW 23679 |
| Contact | Alan Chang |
| Correspondent | Alan Chang APEX MEDICAL CORP. NO. 9, MIN SHENG ST., TU-CHENG, New Taipei City, TW 23679 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-09 |
| Decision Date | 2014-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14713025000155 | K141522 | 000 |
| 04713025000141 | K141522 | 000 |
| 04713025000134 | K141522 | 000 |