The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Ich Cpap Series (9s-007xxx).
| Device ID | K120035 |
| 510k Number | K120035 |
| Device Name: | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-04 |
| Decision Date | 2012-05-16 |
| Summary: | summary |