Decision Date2023-06-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
e-Celsius Medical System is the device name listed in this FDA 510(k) record. The listed applicant is Bodycap. It received FDA 510(k) clearance on 2023-06-28 under 510(k) number K210924. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the e-Celsius Medical System?
e-Celsius Medical System is a medical device that received FDA 510(k) clearance on 2023-06-28. The listed applicant is Bodycap. The 510(k) number is K210924.
When did e-Celsius Medical System receive FDA 510(k) clearance?
e-Celsius Medical System received FDA 510(k) clearance on 2023-06-28, under 510(k) number K210924.
Who is the listed applicant for e-Celsius Medical System?
The FDA 510(k) record lists Bodycap as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for e-Celsius Medical System?
The FDA product code for e-Celsius Medical System is FLL.
Related Devices (Code: FLL)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.