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FDA 510(k)

CLINICAL LASETTE P-200

K-Number: K033799 · 2003-12-22

ApplicantCell Robotics, Inc.
Decision Date2003-12-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLINICAL LASETTE P-200 is the device name listed in this FDA 510(k) record. The listed applicant is Cell Robotics, Inc.. It received FDA 510(k) clearance on 2003-12-22 under 510(k) number K033799. 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 CLINICAL LASETTE P-200?

CLINICAL LASETTE P-200 is a medical device that received FDA 510(k) clearance on 2003-12-22. The listed applicant is Cell Robotics, Inc.. The 510(k) number is K033799.

When did CLINICAL LASETTE P-200 receive FDA 510(k) clearance?

CLINICAL LASETTE P-200 received FDA 510(k) clearance on 2003-12-22, under 510(k) number K033799.

Who is the listed applicant for CLINICAL LASETTE P-200?

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

What is the FDA product code for CLINICAL LASETTE P-200?

The FDA product code for CLINICAL LASETTE P-200 is GEX. This falls under the Gastroenterology category.

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Other records listing Cell Robotics, Inc. as applicant

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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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