FDA.reportPublic FDA data

PYREXAR MEDICAL INC.

Matched from indexed company URL: Pyrexar Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115148223011514822PYREXAR MEDICAL INC.1N2020-04-251825 W RESEARCH WAY STE E Salt Lake City UT US 84119

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00864445000403BSD-2000 Hyperthermia System - The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.+1(844)797-3927regulatory@pyrexar.com
00864445000434BSD-500 Hyperthermia System - The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.+1(844)797-3927regulatory@pyrexar.com
00864445000441BSD-2000 Hyperthermia System - The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.+1(844)797-3927regulatory@pyrexar.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1828031287319755P820088BSD 1000 HYPERTHERMIA SYSTEMLOC1983-11-28
1828031378498442H090002

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOC 11983-11-28

PMA#

GUDID#