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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injection Data Capture Device
510(k) Number K241803
Device Name INSULCLOCK® v2.0 PRO
Applicant
Insulcloud S.L.
Avenida Sabino Arana, #8, 2
Bibao,  ES 48013
Applicant Contact Pilar Aranda
Correspondent
RQM+
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Dulciana Chan
Regulation Number880.5860
Classification Product Code
QOG  
Date Received06/21/2024
Decision Date 08/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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