CARDIO ID+(RZ153+)

Recorder, Magnetic Tape, Medical

ROZINN ELECTRONICS, INC.

The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Cardio Id+(rz153+).

Pre-market Notification Details

Device IDK022540
510k NumberK022540
Device Name:CARDIO ID+(RZ153+)
ClassificationRecorder, Magnetic Tape, Medical
Applicant ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale,  NY  11385
ContactMark Rosoff
CorrespondentMark Rosoff
ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale,  NY  11385
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-01
Decision Date2002-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04250903201219 K022540 000
04250903200298 K022540 000
04250903200281 K022540 000
04250903200274 K022540 000
04250903200267 K022540 000
04250903200250 K022540 000
04250903200243 K022540 000

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