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FDA 510(k)

NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

K-Number: K063477 · 2007-02-09

ApplicantNovamed, LLC
Decision Date2007-02-09
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET is the device name listed in this FDA 510(k) record. The listed applicant is Novamed, LLC. It received FDA 510(k) clearance on 2007-02-09 under 510(k) number K063477. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET?

NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET is a medical device that received FDA 510(k) clearance on 2007-02-09. The listed applicant is Novamed, LLC. The 510(k) number is K063477.

When did NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET receive FDA 510(k) clearance?

NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET received FDA 510(k) clearance on 2007-02-09, under 510(k) number K063477.

Who is the listed applicant for NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET?

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

What is the FDA product code for NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET?

The FDA product code for NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET is CCW.

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Other records listing Novamed, LLC 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.

K062020LIFESOUND ESOPHAGEAL STETHOSCOPE

Related Devices (Code: CCW)

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.

K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLCK121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.K062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, Inc.K062231MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001Minrad, Inc.

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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