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FDA 510(k)

AERO-MIST NEBULIZER

K-Number: K881812 · 1988-07-18

ApplicantCadema Medical Products, Inc.
Decision Date1988-07-18
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AERO-MIST NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Cadema Medical Products, Inc.. It received FDA 510(k) clearance on 1988-07-18 under 510(k) number K881812. The device is classified under product code IYT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AERO-MIST NEBULIZER?

AERO-MIST NEBULIZER is a medical device that received FDA 510(k) clearance on 1988-07-18. The listed applicant is Cadema Medical Products, Inc.. The 510(k) number is K881812.

When did AERO-MIST NEBULIZER receive FDA 510(k) clearance?

AERO-MIST NEBULIZER received FDA 510(k) clearance on 1988-07-18, under 510(k) number K881812.

Who is the listed applicant for AERO-MIST NEBULIZER?

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

What is the FDA product code for AERO-MIST NEBULIZER?

The FDA product code for AERO-MIST NEBULIZER is IYT.

Related Clinical Trials

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Other records listing Cadema Medical Products, Inc. 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.

K901476MODIFIED ENTRAPPING FILTERK896773DISPOSABLE FACE MASKK896116ENTRAPPING FILTERK873930AEROSOL DELIVERY SYSTEM (AERO-TECH II)K800023LUNG AEROSOL UNIT

Related Devices (Code: IYT)

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.

K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc.K200916Patient Administration SetCyclomedica Australia Pty, Ltd.K953513XENON CIRCUITKing Systems Corp.K952223XENON GAS BREATHING CIRCUITIntertech Resources, Inc.K914747XENON CIRCUITGibeck, Inc.K913416TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.

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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