Diasonics 3.5 Gwa 30MM Probe
FDA 510(k) K860361 · Diasonics, Inc.
510(k) numberK860361
Submission
- Device name
- Diasonics 3.5 Gwa 30MM Probe
- Applicant
- Diasonics, Inc.
Milipitas, CA, US - Received
- January 30, 1986
- Decision date
- May 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Diasonics 3.5 Gwa 30MM Probe cleared by the FDA?
Diasonics 3.5 Gwa 30MM Probe (K860361) received a 510(k) decision of Substantially Equivalent on May 27, 1986, 117 days after the submission was received.
What is the product code of K860361?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.