SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL

Cable, Transducer And Electrode, Patient, (including Connector)

CURBELL ELECTRONICS INC.

The following data is part of a premarket notification filed by Curbell Electronics Inc. with the FDA for Sure-lock Electrode Clip, Model Cl-34, Cl-a60, Cl-hw, Cl-tl.

Pre-market Notification Details

Device IDK080605
510k NumberK080605
Device Name:SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant CURBELL ELECTRONICS INC. 20 CENTRE DR. Orchard Park,  NY  14127
ContactMichael J Winter
CorrespondentMichael J Winter
CURBELL ELECTRONICS INC. 20 CENTRE DR. Orchard Park,  NY  14127
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-04
Decision Date2008-05-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840828188944 K080605 000
00840828183376 K080605 000
00840828183383 K080605 000
00840828183390 K080605 000
00840828183406 K080605 000
00840828183413 K080605 000
00840828183420 K080605 000
10812345022176 K080605 000
00840828110426 K080605 000
00840828127370 K080605 000
00840828127387 K080605 000
00840828127394 K080605 000
00840828131254 K080605 000
00840828183369 K080605 000
00840828183352 K080605 000
00840828183345 K080605 000
00840828188760 K080605 000
00840828188869 K080605 000
00840828187428 K080605 000
00840828187442 K080605 000
00840828185912 K080605 000
00840828185929 K080605 000
00840828185936 K080605 000
00840828185943 K080605 000
00840828183840 K080605 000
00840828183505 K080605 000
00840828183321 K080605 000
00840828183338 K080605 000
00840828131261 K080605 000
00840828140546 K080605 000
00840828146838 K080605 000
00840828146845 K080605 000
00840828146869 K080605 000
00840828146876 K080605 000
00840828146883 K080605 000
00840828149136 K080605 000
00840828149143 K080605 000
00840828155830 K080605 000
00840828157452 K080605 000
00840828161978 K080605 000
00840828164948 K080605 000
00840828179652 K080605 000
00840828146326 K080605 000
00840828140683 K080605 000
00840828140676 K080605 000
00840828140553 K080605 000
00840828140560 K080605 000
00840828140577 K080605 000
00840828140584 K080605 000
00840828140591 K080605 000
00840828140607 K080605 000
00840828140614 K080605 000
00840828140621 K080605 000
00840828140638 K080605 000
00840828140645 K080605 000
00840828140652 K080605 000
00840828140669 K080605 000
00884838055384 K080605 000

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