K170965 is an FDA 510(k) clearance for the Fingertip Pulse Oximeter. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Jumper Medical Equipment Co., Ltd. (Baoan District, Shenzhen, CN). The FDA issued a Cleared decision on November 3, 2017, 217 days after receiving the submission on March 31, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K170965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2017 |
| Decision Date | November 03, 2017 |
| Days to Decision | 217 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |