HF Module with Transducers
FDA 510(k) K031391 · Ophthalmic Technologies, Inc.
510(k) numberK031391
Submission
- Device name
- HF Module with Transducers
- Applicant
- Ophthalmic Technologies, Inc.
Hasbrouck, NJ, US - Received
- May 2, 2003
- Decision date
- June 20, 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 HF Module with Transducers cleared by the FDA?
HF Module with Transducers (K031391) received a 510(k) decision of Substantially Equivalent on June 20, 2003, 49 days after the submission was received.
What is the product code of K031391?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.