The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Humidcare Heated Humidifier, Model 9s-004.
| Device ID | K062664 |
| 510k Number | K062664 |
| Device Name: | HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| 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 | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-07 |
| Decision Date | 2006-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14713025000094 | K062664 | 000 |
| 14713025000087 | K062664 | 000 |
| 14713025000063 | K062664 | 000 |
| 14713025000049 | K062664 | 000 |
| 14713025000025 | K062664 | 000 |