Mark V Duplex Ultrasonic Scan Sys.
FDA 510(k) K802438 · Advanced Technology Laboratories, Inc.
510(k) numberK802438
Submission
- Device name
- Mark V Duplex Ultrasonic Scan Sys.
- Applicant
- Advanced Technology Laboratories, Inc.
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- January 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Mark V Duplex Ultrasonic Scan Sys. cleared by the FDA?
Mark V Duplex Ultrasonic Scan Sys. (K802438) received a 510(k) decision of Substantially Equivalent on January 21, 1981, 107 days after the submission was received.
What is the product code of K802438?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.