The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Wizard 510 Nasal Mask.
| Device ID | K193206 |
| 510k Number | K193206 |
| Device Name: | WiZARD 510 Nasal Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Apex Medical Corp. No. 9, Min Sheng St. Tu-Cheng. New Taipei City, TW 23679 |
| Contact | Chieh Yang |
| Correspondent | Chieh Yang 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 | 2019-11-20 |
| Decision Date | 2020-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713025001872 | K193206 | 000 |
| 14713025001862 | K193206 | 000 |