Submission Details
| 510(k) Number | K102138 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 2010 |
| Decision Date | October 28, 2010 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
Oct 2010
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K102138 is an FDA 510(k) clearance for the ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER, a Monitor, Fetal Doppler Ultrasound (Class II — Special Controls, product code MAA), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on October 28, 2010, 90 days after receiving the submission on July 30, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.
Device Classification
| Product Code | MAA — Monitor, Fetal Doppler Ultrasound |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2660 |
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