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FDA 510(k)

TRU-MR LARYNGOSCOPE SET

K-Number: K062523 · 2006-11-17

Decision Date2006-11-17
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRU-MR LARYNGOSCOPE SET is the device name listed in this FDA 510(k) record. The listed applicant is Truphatek International, Ltd.. It received FDA 510(k) clearance on 2006-11-17 under 510(k) number K062523. 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 TRU-MR LARYNGOSCOPE SET?

TRU-MR LARYNGOSCOPE SET is a medical device that received FDA 510(k) clearance on 2006-11-17. The listed applicant is Truphatek International, Ltd.. The 510(k) number is K062523.

When did TRU-MR LARYNGOSCOPE SET receive FDA 510(k) clearance?

TRU-MR LARYNGOSCOPE SET received FDA 510(k) clearance on 2006-11-17, under 510(k) number K062523.

Who is the listed applicant for TRU-MR LARYNGOSCOPE SET?

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

What is the FDA product code for TRU-MR LARYNGOSCOPE SET?

The FDA product code for TRU-MR LARYNGOSCOPE SET is CCW.

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.

Other records listing Truphatek International, Ltd. 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.

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.

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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