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FDA 510(k)

ROSC-U Mini Chest Compressor (RMCC)

K-Number: K153628 · 2016-01-30

ApplicantResuscitation International, LLC
Decision Date2016-01-30
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROSC-U Mini Chest Compressor (RMCC) is a medical device manufactured by Resuscitation International, LLC. It received FDA 510(k) clearance on 2016-01-30 under approval number K153628. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSC-U Mini Chest Compressor (RMCC)?

ROSC-U Mini Chest Compressor (RMCC) is a medical device that received FDA 510(k) clearance on 2016-01-30. It is manufactured by Resuscitation International, LLC. The 510(k) number is K153628.

When was ROSC-U Mini Chest Compressor (RMCC) approved by the FDA?

ROSC-U Mini Chest Compressor (RMCC) received FDA 510(k) clearance on 2016-01-30, under approval number K153628.

What company makes ROSC-U Mini Chest Compressor (RMCC)?

ROSC-U Mini Chest Compressor (RMCC) is manufactured by Resuscitation International, LLC.

What is the FDA product code for ROSC-U Mini Chest Compressor (RMCC)?

The FDA product code for ROSC-U Mini Chest Compressor (RMCC) is DRM.

Related Devices (Code: DRM)

K161768LUCAS 3 Chest Compression SystemJolife AB K173553LUCAS 3 Chest Compression SystemJolife AB K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.

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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