FDA.reportPublic FDA data

510(k) K895609

Device
PUPIL PATHWAY ANALYZER (PPA)
Applicant
PULSE MEDICAL INSTRUMENTS
510(k) number
K895609
Product code
HLG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-02
Date received
1989-09-18
Regulation
886.1700
Classification name
Pupillometer, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JUDY C LINDSTROM
Address
130 Mccormick Ave. Suite 112 Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920937COMPUTERIZED PUPILTrek Medical Products, Inc.1992-10-02
K802351F110 PHOTO BINOCULAR OPHTHALMOSCOPEMinami, Tomine & Lew1980-12-17

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases