OR-340 Intraoperative Ultrasound System
FDA 510(k) K900881 · Codman & Shurtleff, Inc.
510(k) numberK900881
Submission
- Device name
- OR-340 Intraoperative Ultrasound System
- Applicant
- Codman & Shurtleff, Inc.
Attleboro, MA, US - Received
- February 26, 1990
- Decision date
- September 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was OR-340 Intraoperative Ultrasound System cleared by the FDA?
OR-340 Intraoperative Ultrasound System (K900881) received a 510(k) decision of Substantially Equivalent on September 25, 1990, 211 days after the submission was received.
What is the product code of K900881?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.