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FDA 510(k)

EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM

K-Number: K973576 · 1997-12-09

ApplicantEpulse Technologies, Inc.
Decision Date1997-12-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Epulse Technologies, Inc.. It received FDA 510(k) clearance on 1997-12-09 under 510(k) number K973576. 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 EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM?

EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-09. The listed applicant is Epulse Technologies, Inc.. The 510(k) number is K973576.

When did EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM receive FDA 510(k) clearance?

EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM received FDA 510(k) clearance on 1997-12-09, under 510(k) number K973576.

Who is the listed applicant for EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM?

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

What is the FDA product code for EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM?

The FDA product code for EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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