MOBILETT Elara Max
FDA 510(k) K182639 · Siemens Medi Cal Solutions, Inc.
510(k) numberK182639
Submission
- Device name
- MOBILETT Elara Max
- Applicant
- Siemens Medi Cal Solutions, Inc.
Malvern, PA, US - Received
- September 24, 2018
- Decision date
- March 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MOBILETT Elara Max cleared by the FDA?
MOBILETT Elara Max (K182639) received a 510(k) decision of Substantially Equivalent on March 15, 2019, 172 days after the submission was received.
What is the product code of K182639?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.