Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter
FDA 510(k) K121243 · MEDA Co., Ltd.
510(k) numberK121243
Submission
- Device name
- Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter
- Applicant
- MEDA Co., Ltd.
Potomac, MD, US - Received
- April 25, 2012
- Decision date
- May 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter cleared by the FDA?
Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter (K121243) received a 510(k) decision of Substantially Equivalent on May 3, 2013, 373 days after the submission was received.
What is the product code of K121243?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.