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FDA 510(k)

PREFILLED NEBULIZER

K-Number: K810218 · 1981-03-04

ApplicantCorpak Co.
Decision Date1981-03-04
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREFILLED NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810218. 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 PREFILLED NEBULIZER?

PREFILLED NEBULIZER is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Corpak Co.. The 510(k) number is K810218.

When did PREFILLED NEBULIZER receive FDA 510(k) clearance?

PREFILLED NEBULIZER received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810218.

Who is the listed applicant for PREFILLED NEBULIZER?

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

What is the FDA product code for PREFILLED NEBULIZER?

The FDA product code for PREFILLED NEBULIZER is CAF.

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Other records listing Corpak Co. 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.

K935512CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACOREK931921CORPAK GASTROSTOMY TUBEK932847CORPAK ENTERAL PUMPK902949CORPAK GRASPING FORCEPSK901501CORPAK GASTROSTOMY TUBEK882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE

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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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