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FDA 510(k)

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

K-Number: K122857 · 2012-11-07

ApplicantPegasus Research Corp.
Decision Date2012-11-07
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Research Corp.. It received FDA 510(k) clearance on 2012-11-07 under 510(k) number K122857. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100?

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Pegasus Research Corp.. The 510(k) number is K122857.

When did HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 receive FDA 510(k) clearance?

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 received FDA 510(k) clearance on 2012-11-07, under 510(k) number K122857.

Who is the listed applicant for HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100?

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

What is the FDA product code for HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100?

The FDA product code for HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 is CAF.

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Other records listing Pegasus Research Corp. as applicant

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K020700PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPYK013856PMH 1000 HEATED HUMIDIFIERK983783HEATED HUMIDIFIERK962534THERA-MIST NEBULIZER MODEL-P3000K946057AQUALARM MOISTURE SENSOR MODEL P85000K915890AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED

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Related Devices (Code: CAF)

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , 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.

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