PERFORMER HT/ HANG&GO HT BASIC

Warmer, Thermal, Infusion Fluid

RAND S.R.L.

The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Performer Ht/ Hang&go Ht Basic.

Pre-market Notification Details

Device IDK120026
510k NumberK120026
Device Name:PERFORMER HT/ HANG&GO HT BASIC
ClassificationWarmer, Thermal, Infusion Fluid
Applicant RAND S.R.L. VIA STATALE 12,62 Medolla, (mo),  IT 41036
ContactSimone Ceretti
CorrespondentSimone Ceretti
RAND S.R.L. VIA STATALE 12,62 Medolla, (mo),  IT 41036
Product CodeLGZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-05-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M640R99000900001 K120026 000
M640R51000710031 K120026 000
M640R51000710001 K120026 000
M640R51000710041 K120026 000
M640R99000900011 K120026 000
M640R99000900021 K120026 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.