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FDA 510(k)

AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)

K-Number: K890342 · 1989-04-27

ApplicantEastmed Enterprises, Inc.
Decision Date1989-04-27
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) is the device name listed in this FDA 510(k) record. The listed applicant is Eastmed Enterprises, Inc.. It received FDA 510(k) clearance on 1989-04-27 under 510(k) number K890342. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)?

AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) is a medical device that received FDA 510(k) clearance on 1989-04-27. The listed applicant is Eastmed Enterprises, Inc.. The 510(k) number is K890342.

When did AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) receive FDA 510(k) clearance?

AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) received FDA 510(k) clearance on 1989-04-27, under 510(k) number K890342.

Who is the listed applicant for AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)?

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

What is the FDA product code for AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)?

The FDA product code for AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) is BTO.

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Other records listing Eastmed Enterprises, Inc. as applicant

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Related Devices (Code: BTO)

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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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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