The following data is part of a premarket notification filed by Leadtek Research Inc. with the FDA for Leadtek Fingertip Pulse Oximeter (wireless), Leadtek Fingertip Pulse Oximeter (wireless).
| Device ID | K210032 |
| 510k Number | K210032 |
| Device Name: | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) |
| Classification | Oximeter |
| Applicant | Leadtek Research Inc. 18F, No. 166, Jian-Yi Rd., Chung Ho Dist. New Taipei City, TW 23511 |
| Contact | Kun-shan Lu |
| Correspondent | Sharon Peng Leadtek Research Inc. 18F, No. 166, Jian-Yi Rd., Chung Ho Dist. New Taipei City, TW 23511 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-05 |
| Decision Date | 2021-09-01 |