Ihealth Fingertip Pulse Oximeter
510(k) K131111
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131111 | Date11 Sep 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQA
- FDA applicant
- Andon Health Co, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Ihealth Fingertip Pulse Oximeter is a non-invasive device for spot-checking functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is a portable fingertip device intended for adult patients in home and hospital settings. The device measures oxygen saturation of functional hemoglobin, though high levels of dysfunctional hemoglobin may affect measurement accuracy.
The device is supplied as a Class 2 Anesthesiology device with product code DQA. It is manufactured by Andon Health Co., Ltd. and received FDA 510(k) clearance through the Traditional pathway after a 145-day review. The device is not specified as single-use or reusable, and no MRI safety information is provided.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 27 Sep 2026
What is the Ihealth Fingertip Pulse Oximeter used for?
The Ihealth Fingertip Pulse Oximeter is a non-invasive device designed for spot-checking functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult patients. It is portable and intended for use in both home and hospital settings.
How is the Ihealth Fingertip Pulse Oximeter supplied?
The device is supplied as a Class 2 Anesthesiology device with product code DQA. It is manufactured by Andon Health Co., Ltd. and received FDA 510(k) clearance through the Traditional pathway after a 145-day review.
Is the Ihealth Fingertip Pulse Oximeter single-use or reusable?
The device is not specified as single-use or reusable in the provided information. Users should refer to the manufacturer's instructions for proper usage and maintenance guidelines.
What factors may affect the measurement accuracy of the Ihealth Fingertip Pulse Oximeter?
High levels of dysfunctional hemoglobin may affect the measurement accuracy of the device. The device measures oxygen saturation of functional hemoglobin, so clinical judgment should be exercised when interpreting results, especially in patients with known hemoglobin abnormalities.