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FDA 510(k)

OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ

K-Number: K841322 · 1984-07-18

ApplicantAirmed Corp.
Decision Date1984-07-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ is the device name listed in this FDA 510(k) record. The listed applicant is Airmed Corp.. It received FDA 510(k) clearance on 1984-07-18 under 510(k) number K841322. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ?

OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ is a medical device that received FDA 510(k) clearance on 1984-07-18. The listed applicant is Airmed Corp.. The 510(k) number is K841322.

When did OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ receive FDA 510(k) clearance?

OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ received FDA 510(k) clearance on 1984-07-18, under 510(k) number K841322.

Who is the listed applicant for OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ?

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

What is the FDA product code for OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ?

The FDA product code for OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ is FLL.

Related Clinical Trials

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Other records listing Airmed Corp. 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.

K841378VENT-WELL VENTILATOR TUBINGK841321AIR-NEB NEBULIZER COMPRESSOR UNIT

Related Devices (Code: FLL)

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.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., 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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