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FDA 510(k)

e-Celsius Medical System

K-Number: K210924 · 2023-06-28

ApplicantBodycap
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.

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Related Devices (Code: FLL)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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