Identifiers
- 510(k) Number
- K142687 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A pulse oximeter is a non-invasive medical device used to measure oxygen saturation (SpO2) and pulse rate in patients. It operates by transmitting light through a body part, typically a fingertip, and analyzing the absorption characteristics to determine arterial oxygen levels.
This device is supplied as a reusable or single-use sensor depending on the model and is intended for use in clinical and home care settings. It is not indicated as MRI safe unless specified, and storage conditions should follow manufacturer guidelines. The device has received FDA 510(k) clearance under K142687, with product code DQA, and is classified as substantially equivalent to a predicate device.
Frequently asked questions
What is the pulse oximeter used for?
The pulse oximeter is used to non-invasively measure oxygen saturation (SpO2) and pulse rate in patients by transmitting light through a body part, typically a fingertip, and analyzing light absorption to determine arterial oxygen levels.
How is the pulse oximeter supplied and is it reusable or single-use?
The device is supplied as either a reusable or single-use sensor depending on the specific model, allowing flexibility for use in both clinical and home care settings based on infection control needs and cost considerations.
What are the storage and safety considerations for this pulse oximeter?
The pulse oximeter is not indicated as MRI safe unless otherwise specified, and storage conditions must follow the manufacturer’s guidelines to ensure device accuracy and longevity; improper storage may affect sensor performance or calibration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pulse Oximeter-Berry Electronic, Pulse Oximeter Manufacturer | Berrymed, Shanghai Berry Electronic Tech Co., Ltd. - Made-in-China.com, Shanghai Berry Electronic Tech Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142687 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Berry Electronic Tech Co., Ltd.
Sources (1)
- FDA 510(k) K142687 24 fields · synced Sep 21, 2026