Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE

K-Number: K903694 · 1990-10-03

ApplicantAmici, Inc.
Decision Date1990-10-03
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Amici, Inc.. It received FDA 510(k) clearance on 1990-10-03 under 510(k) number K903694. 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 AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE?

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Amici, Inc.. The 510(k) number is K903694.

When did AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE receive FDA 510(k) clearance?

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE received FDA 510(k) clearance on 1990-10-03, under 510(k) number K903694.

Who is the listed applicant for AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE?

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

What is the FDA product code for AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE?

The FDA product code for AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE is IYT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Amici, 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.

K063716AEROSOL SYSTEMK952910THE SWIRLER NEBULIZERK952893THE SWIRLER AEROSOL SYSTEMK904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONK903805AMICI XENON ADMINISTRATION SETK872920AMICI KRYPTON ADMINISTRATION SYSTEM*

View all 8 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑