Submission Details
| 510(k) Number | K180380 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 12, 2018 |
| Decision Date | December 21, 2018 |
| Days to Decision | 312 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
vital signs monitor
Dec 2018
Decision
312d
Days
Class 2
Risk
About This 510(k) Submission
K180380 is an FDA 510(k) clearance for the vital signs monitor, a Oximeter (Class II — Special Controls, product code DQA), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 21, 2018, 312 days after receiving the submission on February 12, 2018. This device falls under the Cardiovascular 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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