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FDA 510(k)

ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39

K-Number: K963193 · 1996-11-13

ApplicantTransamerican Technologies Intl.
Decision Date1996-11-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 is the device name listed in this FDA 510(k) record. The listed applicant is Transamerican Technologies Intl.. It received FDA 510(k) clearance on 1996-11-13 under 510(k) number K963193. 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 ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39?

ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 is a medical device that received FDA 510(k) clearance on 1996-11-13. The listed applicant is Transamerican Technologies Intl.. The 510(k) number is K963193.

When did ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 receive FDA 510(k) clearance?

ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 received FDA 510(k) clearance on 1996-11-13, under 510(k) number K963193.

Who is the listed applicant for ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39?

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

What is the FDA product code for ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39?

The FDA product code for ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 is GEX. This falls under the Gastroenterology category.

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Official Source

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