The following data is part of a premarket notification filed by Taiwan Aulisa Medical Devices Technologies, Inc. with the FDA for Guardian Angel Rx Ga2001 Digital Vital Sign Monitoring System.
| Device ID | K191207 |
| 510k Number | K191207 |
| Device Name: | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System |
| Classification | Oximeter |
| Applicant | Taiwan Aulisa Medical Devices Technologies, Inc. Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., Nangang Dist. Taipei City, TW 115 |
| Contact | Paul Liu |
| Correspondent | Don Mizota Don Mizota 725 Morninghome Road Danville, CA 94526 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-06-25 |