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FDA 510(k)

EMBLETTA MPR

K-Number: K122516 · 2013-02-21

ApplicantEmbla Systems
Decision Date2013-02-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMBLETTA MPR is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2013-02-21 under 510(k) number K122516. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBLETTA MPR?

EMBLETTA MPR is a medical device that received FDA 510(k) clearance on 2013-02-21. The listed applicant is Embla Systems. The 510(k) number is K122516.

When did EMBLETTA MPR receive FDA 510(k) clearance?

EMBLETTA MPR received FDA 510(k) clearance on 2013-02-21, under 510(k) number K122516.

Who is the listed applicant for EMBLETTA MPR?

The FDA 510(k) record lists Embla Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMBLETTA MPR?

The FDA product code for EMBLETTA MPR is MNR.

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Related Devices (Code: MNR)

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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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