The following data is part of a premarket notification filed by Leadtek Research Inc. with the FDA for Leadtek Fingertip Pulse Oximeter.
| Device ID | K193350 |
| 510k Number | K193350 |
| Device Name: | Leadtek Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Leadtek Research Inc. 18F, No.166, Jian-Yi Rd., Zhonghe Dist New Taipei City, TW 23511 |
| Contact | K. S. Lu |
| Correspondent | Sharon Peng Leadtek Research Inc. 18F, No.166, Jian-Yi Rd., Zhonghe Dist New Taipei City, TW 23511 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-03 |
| Decision Date | 2020-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190263830145 | K193350 | 000 |
| 00190263830138 | K193350 | 000 |