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FDA 510(k)

ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN

K-Number: K844765 · 1985-04-08

ApplicantLaser Spectrum, Inc.
Decision Date1985-04-08
Product CodeEWQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Laser Spectrum, Inc.. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K844765. The device is classified under product code EWQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN?

ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Laser Spectrum, Inc.. The 510(k) number is K844765.

When did ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN receive FDA 510(k) clearance?

ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN received FDA 510(k) clearance on 1985-04-08, under 510(k) number K844765.

Who is the listed applicant for ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN?

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

What is the FDA product code for ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN?

The FDA product code for ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN is EWQ.

Related Clinical Trials

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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Other records listing Laser Spectrum, 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.

K863520CO2 LASER MICROMANIPULATORK841781MODEL 305AA PORTABLE LASERK842498DANIELL DBL PUNCTURE LASER LAPAROSCOPYK841668CO2 LAPAROSCOPE

Related Devices (Code: EWQ)

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.

K800669FELDMAN MINI-SAW, #300000KARL STORZ Endoscopy-America, Inc.

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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