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FDA 510(k)

AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000

K-Number: K914465 · 1992-03-31

ApplicantPegasus Research Corp.
Decision Date1992-03-31
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 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 1992-03-31 under 510(k) number K914465. 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 AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000?

AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 is a medical device that received FDA 510(k) clearance on 1992-03-31. The listed applicant is Pegasus Research Corp.. The 510(k) number is K914465.

When did AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 receive FDA 510(k) clearance?

AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 received FDA 510(k) clearance on 1992-03-31, under 510(k) number K914465.

Who is the listed applicant for AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000?

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 AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000?

The FDA product code for AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 is CAF.

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Other records listing Pegasus Research Corp. as applicant

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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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