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510(k) K911650

Device
PEDIA PALS
Applicant
PEDIA PALS, INC.
510(k) number
K911650
Product code
ERA  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-17
Date received
1991-04-12
Regulation
874.4770
Classification name
Otoscope
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HANSEL, JR.
Address
P.O. Box 21934 1964 Collingwood Rd. Columbus OH US 43221 43221

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ERA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123821AIO HD OTOSCOPEBlue Focus2013-05-17
K121326LANTOS 3D EAR SCANNERLantos Technologies2013-01-25
K110326OSRAM ITOSOsram Sylvania, Inc.2011-10-27
K945264OPTUS OTOSCOPESOptus, Inc.1996-02-02
K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.1995-11-14
K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.1995-07-10
K950913PERFECT, ENT SET, PRAKTIKANT, DE LUXERudolf Riester GmbH & Co. KG1995-05-12
K950788OTOSCOPE A-34Neitz Instruments Company, Ltd.1995-05-03
K951050SPECULUM, ENT (S3)Pedia Pals, Inc.1995-04-17
K951049SPECULUM, ENT (S3)Pedia Pals, Inc.1995-04-17
K951255IMEDGE VIDEO OSTOSCOPE (ANALOG)Introspect, Inc.1995-04-13
K950983IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPEIntrospect, Inc.1995-04-12
K950787WELCH ALLYN OTOSCOPEWelch Allyn, Inc.1995-04-06
K946043H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CGRudolf Riester GmbH & Co. KG1995-03-08
K943721OTOVIEW TELESCOPIC OTOSCOPESSmith & Nephew, Inc.1994-11-18

Legacy Summary#

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FDA Review#

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