K191207 is an FDA 510(k) clearance for the Guardian Angel Rx GA2001 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 June 25, 2019, 50 days after receiving the submission on May 6, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K191207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2019 |
| Decision Date | June 25, 2019 |
| Days to Decision | 50 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |