The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Finger Type Pulse Oximeter.
| Device ID | K151024 |
| 510k Number | K151024 |
| Device Name: | Finger Type Pulse Oximeter |
| Classification | Oximeter |
| Applicant | TAIDOC TECHNOLOGY CORPORATION 6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | C. W. Chen |
| Correspondent | Sharon Peng TAIDOC TECHNOLOGY CORPORATION 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2016-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011764 | K151024 | 000 |
| 00816042013553 | K151024 | 000 |