FDA 510(k)

HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100

K-Number: K062119 · 2006-09-22

Decision Date2006-09-22

Product CodeDRM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products Mfg., LLC. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K062119. 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 HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100?

HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Medical Products Mfg., LLC. The 510(k) number is K062119.

When did HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 receive FDA 510(k) clearance?

HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 received FDA 510(k) clearance on 2006-09-22, under 510(k) number K062119.

Who is the listed applicant for HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100?

The FDA 510(k) record lists Medical Products Mfg., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100?

The FDA product code for HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 is DRM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.