Olympus MH-246R Balloon Sheath, for Female Reproductive Tract Use
FDA 510(k) K982725 · Olympus America, Inc.
510(k) numberK982725
Submission
- Device name
- Olympus MH-246R Balloon Sheath, for Female Reproductive Tract Use
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- August 5, 1998
- Decision date
- October 23, 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 MH-246R Balloon Sheath, for Female Reproductive Tract Use cleared by the FDA?
Olympus MH-246R Balloon Sheath, for Female Reproductive Tract Use (K982725) received a 510(k) decision of Substantially Equivalent on October 23, 1998, 79 days after the submission was received.
What is the product code of K982725?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.