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510(k) K892117

Device
GENTLEHALER(R)
Applicant
SCHERING RESEARCH
510(k) number
K892117
Product code
CCQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-23
Date received
1989-03-31
Regulation
868.5640
Classification name
Nebulizer, Medicinal, Non-ventilatory (atomizer)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALEXANDER GIAQUINTO
Address
2000 Galloping Hill Rd. Kenilworth NJ US 07033 07033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972397EZ SPRAYIntertex Research, Inc.1997-09-23
K964956E-Z SPACER MASK (SMALL)Airpharma, LLC1997-04-23
K961894MDI TUTORMdi Tutor, Inc.1996-08-14
K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.1996-07-25
K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.1996-05-10
K922033SALINE SOLUTION- STERILETrinity Laboratories, Inc.1992-07-21
K900576MODIFIED AEROCHAMBER WITH MASKMonaghan Medical Corp.1991-05-13
K895115FRANK INHALER THERMAL SButtner-Frank GmbH1990-05-18
K894215EVOLUTION ULTRASONICMedical Industries America, Inc.1990-04-16
K894555PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATEDDura Pharmaceuticals, Inc.1990-01-24
K896070PFEIFFER METERED DOSAGE SYSTEMSyva Co.1990-01-17
K895592FREEWAY NEBULIZER COMPRESSORLifecare Services, Inc.1989-11-21
K894441DEVILBISS MODEL 6610DDevilbiss Health Care, Inc.1989-10-13
K894244DEVILBISS MODEL 8500D AND 8500D-608Devilbiss Health Care, Inc.1989-10-06
K875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USPDey Laboratories, Inc.1988-01-22

Legacy Summary#

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FDA Review#

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