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FDA 510(k)

HELICAT

K-Number: K930090 · 1993-03-19

ApplicantElscint, Inc.
Decision Date1993-03-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HELICAT is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1993-03-19 under 510(k) number K930090. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELICAT?

HELICAT is a medical device that received FDA 510(k) clearance on 1993-03-19. The listed applicant is Elscint, Inc.. The 510(k) number is K930090.

When did HELICAT receive FDA 510(k) clearance?

HELICAT received FDA 510(k) clearance on 1993-03-19, under 510(k) number K930090.

Who is the listed applicant for HELICAT?

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 HELICAT?

The FDA product code for HELICAT is JAK.

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Other records listing Elscint, Inc. as applicant

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Related Devices (Code: JAK)

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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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