Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)
FDA 510(k) K982610 · Olympus Optical, Co.
510(k) numberK982610
Submission
- Device name
- Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)
- Applicant
- Olympus Optical, Co.
Melville, NY, US - Received
- July 27, 1998
- Decision date
- November 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) cleared by the FDA?
Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) (K982610) received a 510(k) decision of Substantially Equivalent on November 16, 1998, 112 days after the submission was received.
What is the product code of K982610?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.