CER-S
K-Number: K193177 · 2020-08-26
ApplicantCardiocalm
Decision Date2020-08-26
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CER-S is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocalm. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K193177. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CER-S?
CER-S is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Cardiocalm. The 510(k) number is K193177.
When did CER-S receive FDA 510(k) clearance?
CER-S received FDA 510(k) clearance on 2020-08-26, under 510(k) number K193177.
Who is the listed applicant for CER-S?
The FDA 510(k) record lists Cardiocalm as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CER-S?
The FDA product code for CER-S is MLO.
Related Devices (Code: MLO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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