The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Vacplus Suction Unit.
| Device ID | K103535 |
| 510k Number | K103535 |
| Device Name: | VACPLUS SUCTION UNIT |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | APEX MEDICAL CORP. NO.8, LANE 29, WENMING RD. Guisan, Taoyuan, TW 33383 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2011-02-24 |
| Summary: | summary |