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FDA 510(k)

POWERLITE 600 EX SYSTEM

K-Number: K033933 · 2004-03-16

ApplicantPreswede AB
Decision Date2004-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWERLITE 600 EX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Preswede AB. It received FDA 510(k) clearance on 2004-03-16 under 510(k) number K033933. 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 POWERLITE 600 EX SYSTEM?

POWERLITE 600 EX SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-16. The listed applicant is Preswede AB. The 510(k) number is K033933.

When did POWERLITE 600 EX SYSTEM receive FDA 510(k) clearance?

POWERLITE 600 EX SYSTEM received FDA 510(k) clearance on 2004-03-16, under 510(k) number K033933.

Who is the listed applicant for POWERLITE 600 EX SYSTEM?

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

What is the FDA product code for POWERLITE 600 EX SYSTEM?

The FDA product code for POWERLITE 600 EX SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Preswede AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030423POWERLITE 600 EP SYSTEM

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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