Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract
FDA 510(k) K001203 · The Olympus Optical Co.
510(k) numberK001203
Submission
- Device name
- Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract
- Applicant
- The Olympus Optical Co.
Melville, NY, US - Received
- April 13, 2000
- Decision date
- May 26, 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 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract cleared by the FDA?
Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract (K001203) received a 510(k) decision of Substantially Equivalent on May 26, 2000, 43 days after the submission was received.
What is the product code of K001203?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.