The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for V-trust Handheld Pulse Oximeter Model: Td-8201.
| Device ID | K101012 |
| 510k Number | K101012 |
| Device Name: | V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 |
| Classification | Oximeter |
| Applicant | TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042013836 | K101012 | 000 |