Submission Details
| 510(k) Number | K142832 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2014 |
| Decision Date | February 06, 2015 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
Unimed Disposable and Reusable SPO2 Sensors
Feb 2015
Decision
129d
Days
Class 2
Risk
About This 510(k) Submission
K142832 is an FDA 510(k) clearance for the Unimed Disposable and Reusable SPO2 Sensors, a Oximeter (Class II — Special Controls, product code DQA), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 6, 2015, 129 days after receiving the submission on September 30, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.
Device Classification
| Product Code | DQA — Oximeter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
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