Interoperative Linear/Sector Ultrasound Scanner
FDA 510(k) K855247 · Codman & Shurtleff, Inc.
510(k) numberK855247
Submission
- Device name
- Interoperative Linear/Sector Ultrasound Scanner
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- December 23, 1985
- Decision date
- February 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Interoperative Linear/Sector Ultrasound Scanner cleared by the FDA?
Interoperative Linear/Sector Ultrasound Scanner (K855247) received a 510(k) decision of Substantially Equivalent on February 19, 1987, 423 days after the submission was received.
What is the product code of K855247?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.