Submission Details
| 510(k) Number | K141362 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 2014 |
| Decision Date | April 23, 2015 |
| Days to Decision | 335 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
PULSE OXIMETER CMS50EW
Apr 2015
Decision
335d
Days
Class 2
Risk
About This 510(k) Submission
K141362 is an FDA 510(k) clearance for the PULSE OXIMETER CMS50EW, a Oximeter (Class II — Special Controls, product code DQA), submitted by Contec Medical Systems Co.,Ltd (Shanghai, CN). The FDA issued a Cleared decision on April 23, 2015, 335 days after receiving the submission on May 23, 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 |
Manufacturer
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