FDA 510(k)

BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S

K-Number: K934089 · 1994-02-03

Decision Date1994-02-03

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S is the device name listed in this FDA 510(k) record. The listed applicant is Bio Quantum Technologies, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K934089. 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 BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S?

BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Bio Quantum Technologies, Inc.. The 510(k) number is K934089.

When did BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S receive FDA 510(k) clearance?

BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S received FDA 510(k) clearance on 1994-02-03, under 510(k) number K934089.

Who is the listed applicant for BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S?

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

What is the FDA product code for BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S?

The FDA product code for BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S is GEX. This falls under the Gastroenterology category.

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Other records listing Bio Quantum Technologies, Inc. as applicant

K864946ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE K864887ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU K864948ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE K840406MICROSURGICAL CO2 LASER SYS - 4100 K837110MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM

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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.