The following data is part of a premarket notification filed by Taiwan Aulisa Medical Devices Technologies, Inc. with the FDA for Guardian Angel Ga1000 Digital Vital Sign Monitoring System.
| Device ID | K162580 |
| 510k Number | K162580 |
| Device Name: | Guardian Angel GA1000 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 | Alan Tang |
| Correspondent | Don Mizota TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. 725 MORNINGHOME RD Danville, CA 94526 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2017-03-03 |
| Summary: | summary |