The following data is part of a premarket notification filed by Taiwan Aulisa Medical Devices Technologies, Inc. with the FDA for Aulisa Multiple Patient Digital Vital Sign Monitoring System.
| Device ID | K202497 |
| 510k Number | K202497 |
| Device Name: | Aulisa Multiple Patient Digital Vital Sign Monitoring System |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Taiwan Aulisa Medical Devices Technologies, Inc. Rm. 1052, Bldg. H, 10F., No.32, YuanQu St., Nangang Dist. Taipei City, TW |
| Contact | Paul Liu |
| Correspondent | Don Mizota Taiwan Aulisa Medical Devices Technologies, Inc. 725 Morninghome Road Danville, CA 94526 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2020-10-30 |