K162580 is an FDA 510(k) clearance for the Guardian Angel GA1000 Digital Vital Sign Monitoring System. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on March 3, 2017, 169 days after receiving the submission on September 15, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K162580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2016 |
| Decision Date | March 03, 2017 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |