Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler
FDA 510(k) K102138 · Edan Instruments, Inc.
510(k) numberK102138
Submission
- Device name
- Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler
- Applicant
- Edan Instruments, Inc.
Shenzhen, CN - Received
- July 30, 2010
- Decision date
- October 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAA – Monitor, Fetal Doppler Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler cleared by the FDA?
Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler (K102138) received a 510(k) decision of Substantially Equivalent on October 28, 2010, 90 days after the submission was received.
What is the product code of K102138?
The FDA product code is MAA – Monitor, Fetal Doppler Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 884.2660.