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FDA 510(k)

EVOLUTION ULTRASONIC

K-Number: K894215 · 1990-04-16

ApplicantMedical Industries America, Inc.
Decision Date1990-04-16
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EVOLUTION ULTRASONIC is the device name listed in this FDA 510(k) record. The listed applicant is Medical Industries America, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K894215. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUTION ULTRASONIC?

EVOLUTION ULTRASONIC is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Medical Industries America, Inc.. The 510(k) number is K894215.

When did EVOLUTION ULTRASONIC receive FDA 510(k) clearance?

EVOLUTION ULTRASONIC received FDA 510(k) clearance on 1990-04-16, under 510(k) number K894215.

Who is the listed applicant for EVOLUTION ULTRASONIC?

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

What is the FDA product code for EVOLUTION ULTRASONIC?

The FDA product code for EVOLUTION ULTRASONIC is CCQ.

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Other records listing Medical Industries America, 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.

K050990REMREST HEATED HUMIDIFIERK032170TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000K002763REMRESTK011053OPTIMAK9640783050 SPORT-NEBK9439903000 AEROSOL TWO

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Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, Inc.

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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