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FDA 510(k)

MOBILETT Elara Max

K-Number: K182639 · 2019-03-15

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2019-03-15
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILETT Elara Max is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2019-03-15 under approval number K182639. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILETT Elara Max?

MOBILETT Elara Max is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K182639.

When was MOBILETT Elara Max approved by the FDA?

MOBILETT Elara Max received FDA 510(k) clearance on 2019-03-15, under approval number K182639.

What company makes MOBILETT Elara Max?

MOBILETT Elara Max is manufactured by Siemens Medi Cal Solutions, Inc..

What is the FDA product code for MOBILETT Elara Max?

The FDA product code for MOBILETT Elara Max is IZL.

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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.

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