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FDA 510(k)

JENASCAN

K-Number: K980001 · 1998-03-19

ApplicantJenoptik Laser, Optik, Systeme GmbH
Decision Date1998-03-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JENASCAN is the device name listed in this FDA 510(k) record. The listed applicant is Jenoptik Laser, Optik, Systeme GmbH. It received FDA 510(k) clearance on 1998-03-19 under 510(k) number K980001. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JENASCAN?

JENASCAN is a medical device that received FDA 510(k) clearance on 1998-03-19. The listed applicant is Jenoptik Laser, Optik, Systeme GmbH. The 510(k) number is K980001.

When did JENASCAN receive FDA 510(k) clearance?

JENASCAN received FDA 510(k) clearance on 1998-03-19, under 510(k) number K980001.

Who is the listed applicant for JENASCAN?

The FDA 510(k) record lists Jenoptik Laser, Optik, Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JENASCAN?

The FDA product code for JENASCAN is GEX. This falls under the Gastroenterology category.

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Official Source

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

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