EUP-OL334 Laparascopicprobe
FDA 510(k) K981434 · Hitachi Medical Corp. of America
510(k) numberK981434
Submission
- Device name
- EUP-OL334 Laparascopicprobe
- Applicant
- Hitachi Medical Corp. of America
Saratoga, CA, US - Received
- April 21, 1998
- Decision date
- July 27, 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 EUP-OL334 Laparascopicprobe cleared by the FDA?
EUP-OL334 Laparascopicprobe (K981434) received a 510(k) decision of Substantially Equivalent on July 27, 1998, 97 days after the submission was received.
What is the product code of K981434?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.