Submission Details
| 510(k) Number | K202892 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2020 |
| Decision Date | January 28, 2021 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
Jan 2021
Decision
122d
Days
Class 2
Risk
About This 510(k) Submission
K202892 is an FDA 510(k) clearance for the Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 28, 2021, 122 days after receiving the submission on September 28, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
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