Olympus Ise Module

FDA 510(k) K921718 · Olympus Corp.

Substantially Equivalent

510(k) numberK921718

Submission

Device name
Olympus Ise Module
Applicant
Olympus Corp.
Lake Success, NY, US
Received
April 9, 1992
Decision date
July 21, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JGS – Electrode, Ion Specific, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Specialty
Clinical Chemistry

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Questions and answers

When was Olympus Ise Module cleared by the FDA?

Olympus Ise Module (K921718) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 103 days after the submission was received.

What is the product code of K921718?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.