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FDA 510(k)

ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU

K-Number: K864887 · 1987-04-10

ApplicantBio Quantum Technologies, Inc.
Decision Date1987-04-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU 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 1987-04-10 under 510(k) number K864887. 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 for Some Indications.

Frequently Asked Questions

What is the ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU?

ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is Bio Quantum Technologies, Inc.. The 510(k) number is K864887.

When did ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU receive FDA 510(k) clearance?

ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU received FDA 510(k) clearance on 1987-04-10, under 510(k) number K864887.

Who is the listed applicant for ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU?

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 ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU?

The FDA product code for ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Bio Quantum Technologies, 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.

K934089BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550SK864946ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEK864948ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USEK840406MICROSURGICAL CO2 LASER SYS - 4100K837110MODEL 4100 MICROSURGICAL CO2 LASER 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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