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FDA 510(k)

LARYNGEAL SURFACE ELECTRODE

K-Number: K093373 · 2010-08-24

Decision Date2010-08-24
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LARYNGEAL SURFACE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2010-08-24 under 510(k) number K093373. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARYNGEAL SURFACE ELECTRODE?

LARYNGEAL SURFACE ELECTRODE is a medical device that received FDA 510(k) clearance on 2010-08-24. The listed applicant is Spes Medica Srl. The 510(k) number is K093373.

When did LARYNGEAL SURFACE ELECTRODE receive FDA 510(k) clearance?

LARYNGEAL SURFACE ELECTRODE received FDA 510(k) clearance on 2010-08-24, under 510(k) number K093373.

Who is the listed applicant for LARYNGEAL SURFACE ELECTRODE?

The FDA 510(k) record lists Spes Medica Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LARYNGEAL SURFACE ELECTRODE?

The FDA product code for LARYNGEAL SURFACE ELECTRODE is ETN.

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 Spes Medica Srl 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.

View all 8 devices →

Related Devices (Code: ETN)

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

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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