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510(k) K914251

Device
MODEL IRC PASSPORT NEBULIZER
Applicant
INVACARE CORP.
510(k) number
K914251
Product code
LAW  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-24
Date received
1991-09-23
Regulation
862.3280
Classification name
Theophylline Control Materials
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD A KROLL
Address
899 Cleveland St. P.O. Box 4028 Elyria OH US 44036 44036

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LAW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920223CHEM CHEX THEOPHYLLINE CONTROLStreck Laboratories, Inc.1992-06-10
K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSBiotrack, Inc.1990-09-17
K871589THEOPHYLLINE FPIA CONTROLSSigma Chemical Co.1987-06-17

Legacy Summary#

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FDA Review#

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