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FDA 510(k)

MULTILASE 2500 A

K-Number: K920708 · 1992-11-05

ApplicantTeknomed, Inc.
Decision Date1992-11-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTILASE 2500 A is the device name listed in this FDA 510(k) record. The listed applicant is Teknomed, Inc.. It received FDA 510(k) clearance on 1992-11-05 under 510(k) number K920708. 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 MULTILASE 2500 A?

MULTILASE 2500 A is a medical device that received FDA 510(k) clearance on 1992-11-05. The listed applicant is Teknomed, Inc.. The 510(k) number is K920708.

When did MULTILASE 2500 A receive FDA 510(k) clearance?

MULTILASE 2500 A received FDA 510(k) clearance on 1992-11-05, under 510(k) number K920708.

Who is the listed applicant for MULTILASE 2500 A?

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

What is the FDA product code for MULTILASE 2500 A?

The FDA product code for MULTILASE 2500 A is GEX. This falls under the Gastroenterology category.

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Other records listing Teknomed, Inc. 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.

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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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