K210032 is an FDA 510(k) clearance for the Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Leadtek Research, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on September 1, 2021, 239 days after receiving the submission on January 5, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K210032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2021 |
| Decision Date | September 01, 2021 |
| Days to Decision | 239 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 |