A-Scan 100
FDA 510(k) K024114 · Ophthalmic Technologies, Inc.
510(k) numberK024114
Submission
- Device name
- A-Scan 100
- Applicant
- Ophthalmic Technologies, Inc.
Hasbrouck, NJ, US - Received
- December 13, 2002
- Decision date
- January 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was A-Scan 100 cleared by the FDA?
A-Scan 100 (K024114) received a 510(k) decision of Substantially Equivalent on January 10, 2003, 28 days after the submission was received.
What is the product code of K024114?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.