The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Wizard 230 Nasal Pilow Mask.
| Device ID | K121642 |
| 510k Number | K121642 |
| Device Name: | WIZARD 230 NASAL PILOW MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County, TW 236 |
| Contact | Frank Lin |
| Correspondent | Frank Lin 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 | 2012-06-04 |
| Decision Date | 2013-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713025000622 | K121642 | 000 |
| 14713025000612 | K121642 | 000 |