Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract
FDA 510(k) K994103 · Olympus America, Inc.
510(k) numberK994103
Submission
- Device name
- Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- December 6, 1999
- Decision date
- September 5, 2000
- 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-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract cleared by the FDA?
Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract (K994103) received a 510(k) decision of Substantially Equivalent on September 5, 2000, 274 days after the submission was received.
What is the product code of K994103?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.