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FDA 510(k)

EUP-OL334 LAPARASCOPICPROBE

K-Number: K981434 · 1998-07-27

ApplicantHitachi Medical Corp. of America
Decision Date1998-07-27
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EUP-OL334 LAPARASCOPICPROBE is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1998-07-27 under 510(k) number K981434. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUP-OL334 LAPARASCOPICPROBE?

EUP-OL334 LAPARASCOPICPROBE is a medical device that received FDA 510(k) clearance on 1998-07-27. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K981434.

When did EUP-OL334 LAPARASCOPICPROBE receive FDA 510(k) clearance?

EUP-OL334 LAPARASCOPICPROBE received FDA 510(k) clearance on 1998-07-27, under 510(k) number K981434.

Who is the listed applicant for EUP-OL334 LAPARASCOPICPROBE?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUP-OL334 LAPARASCOPICPROBE?

The FDA product code for EUP-OL334 LAPARASCOPICPROBE is ITX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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