Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D— 510(k) K151287
Substantially EquivalentGuangdong Biolight Meditech Co., Ltd.
FDA 510(k) clearance K151287 for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D, Substantially Equivalent on 2016-01-06. Applicant: Guangdong Biolight Meditech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangdong Biolight Meditech Co., Ltd.
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhuhai,, CN
Recent devices under product code DQA
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Guangdong Biolight Meditech Co., Ltd.
view allAdverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.