FINGERTIP PULSE OXIMETER - M70
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081712 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- Models / Variants
- M70 FDA 510(k)EUDAMED
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)
The Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700 are non-invasive devices designed to measure functional arterial oxygen saturation (SpO₂) and pulse rate. These devices utilise photoplethysmography to monitor oxygen levels in the blood and heart rate, providing critical clinical data for patient assessment.
The M70 is a fingertip device intended for intermittent use in hospital or home care settings, while the M700 is a handheld model for spot-checking SpO₂ and pulse rate. Both devices are classified under product code DQA and have received FDA 510(k) clearance and MDR authorisation. They are not intended for continuous long-term monitoring and are supplied as single-use or reusable devices as specified by the manufacturer.
Frequently asked questions
What is the primary difference between the Model M70 and Model M700 pulse oximeters in terms of their intended use?
The Model M70 is a fingertip pulse oximeter designed for intermittent use in hospital or home care settings, while the Model M700 is a handheld device meant for quick spot-checks of SpO₂ and pulse rate. Neither is intended for continuous long-term monitoring.
Are these pulse oximeters single-use or reusable, and how should they be handled?
The manufacturer specifies whether each model is single-use or reusable, though the provided data does not detail this distinction. For proper handling, follow the manufacturer’s instructions, as usage depends on whether the device is intended for single-use or repeated use in clinical settings.
What clinical measurements do these devices provide, and how do they function?
Both the Model M70 and Model M700 measure functional arterial oxygen saturation (SpO₂) and pulse rate using photoplethysmography—a non-invasive technique that detects blood volume changes in peripheral tissue to estimate oxygen levels and heart rate.
What regulatory pathways have these devices undergone, and which committee reviewed their submission?
These devices received FDA 510(k) clearance and MDR authorization. The submission was reviewed by the Advisory Committee on Cardiovascular Devices (AN) under the product code DQA, with a decision of substantial equivalence (SESE) made on September 12, 2008.
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: Fingertip Pulse Oximeter, Model M70, And Handheld Pulse Oximeter, Model ..., Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model ..., BioLight M70 Fingertip Pulse Oximeter | Suresign Professional
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K081712 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- FDA Applicant
- Guangdong Biolight Meditech Co., Ltd.
Sources (2)
- FDA 510(k) K081712 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026