HOLTER PLUS

Computer, Diagnostic, Programmable

ROZINN ELECTRONICS, INC.

The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Holter Plus.

Pre-market Notification Details

Device IDK042463
510k NumberK042463
Device Name:HOLTER PLUS
ClassificationComputer, Diagnostic, Programmable
Applicant ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale,  NY  11385
ContactMark Rosoff
CorrespondentChris Lavanchy
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-09-13
Decision Date2004-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00856298006268 K042463 000
00856298006237 K042463 000
00856298006169 K042463 000

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