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FDA 510(k)

THERA-MIST NEBULIZER MODEL-P3000

K-Number: K962534 · 1997-02-28

ApplicantPegasus Research Corp.
Decision Date1997-02-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERA-MIST NEBULIZER MODEL-P3000 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 1997-02-28 under 510(k) number K962534. 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 THERA-MIST NEBULIZER MODEL-P3000?

THERA-MIST NEBULIZER MODEL-P3000 is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Pegasus Research Corp.. The 510(k) number is K962534.

When did THERA-MIST NEBULIZER MODEL-P3000 receive FDA 510(k) clearance?

THERA-MIST NEBULIZER MODEL-P3000 received FDA 510(k) clearance on 1997-02-28, under 510(k) number K962534.

Who is the listed applicant for THERA-MIST NEBULIZER MODEL-P3000?

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 THERA-MIST NEBULIZER MODEL-P3000?

The FDA product code for THERA-MIST NEBULIZER MODEL-P3000 is CAF.

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Other records listing Pegasus Research 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.

K122857HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100K020700PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPYK013856PMH 1000 HEATED HUMIDIFIERK983783HEATED HUMIDIFIERK946057AQUALARM 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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