FDA.report

510(k) K881480

Device
FIRST AMERICAN, RADIONIC, JKR, MODEL AC
Applicant
JKR LABORATORIES, INC.
510(k) number
K881480
Product code
ESD  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-11
Date received
1988-04-05
Regulation
874.3300
Classification name
Hearing Aid, Air Conduction
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JERRY BLUE
Address
10701 W. Kellogg P.O. Box 12201 Wichita KS US 67209 67209

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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