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FDA 510(k)

ISOREX LS-36

K-Number: K834496 · 1984-02-21

ApplicantElscint, Inc.
Decision Date1984-02-21
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOREX LS-36 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834496. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOREX LS-36?

ISOREX LS-36 is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Elscint, Inc.. The 510(k) number is K834496.

When did ISOREX LS-36 receive FDA 510(k) clearance?

ISOREX LS-36 received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834496.

Who is the listed applicant for ISOREX LS-36?

The FDA 510(k) record lists Elscint, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOREX LS-36?

The FDA product code for ISOREX LS-36 is IZI.

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Other records listing Elscint, Inc. as applicant

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Related Devices (Code: IZI)

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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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