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FDA 510(k)

COOL-LITE FIBERCOPTIC LARYNGEAL EXAM

K-Number: K830888 · 1983-04-27

ApplicantNational Medical Technology
Decision Date1983-04-27
Product CodeEQN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COOL-LITE FIBERCOPTIC LARYNGEAL EXAM is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Technology. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K830888. The device is classified under product code EQN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOL-LITE FIBERCOPTIC LARYNGEAL EXAM?

COOL-LITE FIBERCOPTIC LARYNGEAL EXAM is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is National Medical Technology. The 510(k) number is K830888.

When did COOL-LITE FIBERCOPTIC LARYNGEAL EXAM receive FDA 510(k) clearance?

COOL-LITE FIBERCOPTIC LARYNGEAL EXAM received FDA 510(k) clearance on 1983-04-27, under 510(k) number K830888.

Who is the listed applicant for COOL-LITE FIBERCOPTIC LARYNGEAL EXAM?

The FDA 510(k) record lists National Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOL-LITE FIBERCOPTIC LARYNGEAL EXAM?

The FDA product code for COOL-LITE FIBERCOPTIC LARYNGEAL EXAM is EQN.

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 National Medical Technology 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.

K871668BIODAN TYPE COMET ELECTRODEK861158S&W TYPE 888 ELECTRODEK790845DUALUME LARYNGEAL EXAMINATION TELESCOPE

Related Devices (Code: EQN)

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.

K252624KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc.K834172OP-CON SURG. INSTRUMENT #7Imm Enterprises , Ltd.K831255LARYNGOSCOPE ATTACHMENT PH2000Eder Instrument Co, Inc.K822525LARYNGOSCOPES RIGIDKelleher Corp.K821707NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHTKelleher Corp.K821709NAGASHIMA LIGHT SOURCE UNIT SL-5Kelleher Corp.

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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