The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Ihealth Fingertip Pulse Oximeter.
| Device ID | K131111 |
| 510k Number | K131111 |
| Device Name: | IHEALTH FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | ANDON HEALTH CO.,LTD #3, JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO.,LTD #3, JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-19 |
| Decision Date | 2013-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855111003917 | K131111 | 000 |