The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Wizard 310/320 Series Cpap Mask.
| Device ID | K182394 |
| 510k Number | K182394 |
| Device Name: | WiZARD 310/320 Series CPAP Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Apex Medical Corp. No. 9 Min Sheng St. Tu-Cheng New Taipei City, TW 23679 |
| Contact | Frank Lin |
| Correspondent | Frank Lin 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 | 2018-09-04 |
| Decision Date | 2019-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14713025000810 | K182394 | 000 |
| 14713025000803 | K182394 | 000 |
| 14713025000797 | K182394 | 000 |
| 14713025000780 | K182394 | 000 |
| 14713025000773 | K182394 | 000 |
| 04713025000769 | K182394 | 000 |