FDA.reportPublic FDA data

510(k) K891927

Device
TELEMETRY POWER PACK MODEL 2
Applicant
LUCAS & RHEA MFG.
510(k) number
K891927
Product code
FCP  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-26
Date received
1989-03-28
Regulation
876.1500
Classification name
Box, Battery, Pocket
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
VIRGINIA RHEA
Address
Rte. 1, Box 12a Lavinia TN US 38348 38348

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881885BATTERY PACKS (OTHER THAN CV)Dowit Service Co., Inc.1988-07-26

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