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FDA 510(k)

RESOLUTIONMD MOBILE MODEL RMB-MOB-2X

K-Number: K111346 · 2011-09-09

ApplicantCalgary Scientific, Inc.
Decision Date2011-09-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RESOLUTIONMD MOBILE MODEL RMB-MOB-2X is the device name listed in this FDA 510(k) record. The listed applicant is Calgary Scientific, Inc.. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K111346. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLUTIONMD MOBILE MODEL RMB-MOB-2X?

RESOLUTIONMD MOBILE MODEL RMB-MOB-2X is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Calgary Scientific, Inc.. The 510(k) number is K111346.

When did RESOLUTIONMD MOBILE MODEL RMB-MOB-2X receive FDA 510(k) clearance?

RESOLUTIONMD MOBILE MODEL RMB-MOB-2X received FDA 510(k) clearance on 2011-09-09, under 510(k) number K111346.

Who is the listed applicant for RESOLUTIONMD MOBILE MODEL RMB-MOB-2X?

The FDA 510(k) record lists Calgary Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLUTIONMD MOBILE MODEL RMB-MOB-2X?

The FDA product code for RESOLUTIONMD MOBILE MODEL RMB-MOB-2X is LLZ.

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Other records listing Calgary Scientific, Inc. as applicant

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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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