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FDA 510(k)

CB ERBIUM/2.94(TM) ER:YAG LASER

K-Number: K970934 · 1997-06-11

ApplicantContinuum Biomedical, Inc.
Decision Date1997-06-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CB ERBIUM/2.94(TM) ER:YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1997-06-11 under 510(k) number K970934. 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 CB ERBIUM/2.94(TM) ER:YAG LASER?

CB ERBIUM/2.94(TM) ER:YAG LASER is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K970934.

When did CB ERBIUM/2.94(TM) ER:YAG LASER receive FDA 510(k) clearance?

CB ERBIUM/2.94(TM) ER:YAG LASER received FDA 510(k) clearance on 1997-06-11, under 510(k) number K970934.

Who is the listed applicant for CB ERBIUM/2.94(TM) ER:YAG LASER?

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

What is the FDA product code for CB ERBIUM/2.94(TM) ER:YAG LASER?

The FDA product code for CB ERBIUM/2.94(TM) ER:YAG LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Continuum Biomedical, 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.

K992013DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASERK983054MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASERK973719MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASERK970808MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASERK971903SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASERK971879SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER

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Related Devices (Code: GEX)

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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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