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FDA 510(k)

OTOVENT

K-Number: K920840 · 1992-10-05

ApplicantAbigo Medical AB
Decision Date1992-10-05
Product CodeMJV
DecisionSubstantially Equivalent

Device Summary

OTOVENT is the device name listed in this FDA 510(k) record. The listed applicant is Abigo Medical AB. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K920840. The device is classified under product code MJV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOVENT?

OTOVENT is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Abigo Medical AB. The 510(k) number is K920840.

When did OTOVENT receive FDA 510(k) clearance?

OTOVENT received FDA 510(k) clearance on 1992-10-05, under 510(k) number K920840.

Who is the listed applicant for OTOVENT?

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

What is the FDA product code for OTOVENT?

The FDA product code for OTOVENT is MJV.

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Other records listing Abigo Medical AB 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.

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Related Devices (Code: MJV)

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.

K252751Earflo (EF001)Earflo, Inc.K230502Ear Pressure Relief Device(Model:ER813B)Ningbo Albert Novosino Co., Ltd.K203754Eustachi Ear Pressure Relief DeviceExercore, LLCK073401EARPOPPER, MODEL EP-2000, EP-2100, EP-3000Micromedics, Inc.K951596EARCLEARArisil Medical

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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