510(k) clearances

CER-S

Cardiocalm Srl · Cardiovascular

K243312Substantially EquivalentTraditionalDQK
Open FDA's page for this record
Third party flag
N
City
Montichiari
Advisory committee description
Cardiovascular
Address 1
Corso Martiri Della Libertà, Nr. 40
Statement or summary
Summary
Product code
DQK
Zip code
25018
Applicant
Cardiocalm Srl
Decision date
2025-02-20
Decision code
SESE
Country code
IT
Device name
CER-S
Advisory committee
CV
Contact
Fabio Badilini
K number
K243312
Date received
2024-10-22
Review advisory committee
CV
Postal code
25018
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Computer, Diagnostic, Programmable
Medical specialty description
Cardiovascular
Regulation number
870.1425
Device class
2
Registration number
3045891669, 2648045, 3009600098, 3033959233, 3008729547, 3013581838, 3006087789, 2030404, 3002672225, 1650907, 3003768277, 2183926, 3017638059, 3009499478, 2438852, 3005334138, 1054713, 3004016520, 3008329188, 2024168, 3004006614, 3010155648, 3010390468, 3017233611, 3015151147, 3004594159, 3016674095, 3017060084, 3026523691, 3012520654, 3007029079, 3007208829, 3018940143, 3016618143, 3010342616, 3012359877, 2246552, 3013679558, 1320894, 3017401510 +145 more
FEI number
3045891669, 2648045, 3009600098, 3033959233, 3002807992, 3008729547, 3013581838, 3006087789, 3002672225, 3017638059, 3009499478, 3005334138, 3004016520, 3008329188, 2024168, 1000221960, 3010155648, 3010390468, 3004006614, 3015151147, 3004594159, 3016674095, 3017233611, 3017060084, 3026523691, 3012520654, 3007029079, 3003081151, 3018940143, 3016618143, 3010342616, 3012359877, 2246552, 3000209794, 3013679558, 3017401510, 3003076831, 3004091615, 3009254201, 1000519796 +145 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.