FDA 510(k)

360 SLX ADVISORY DEFIBRILLATOR

K-Number: K935922 · 1994-12-22

ApplicantMedical Research Laboratories, Inc.

Decision Date1994-12-22

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

360 SLX ADVISORY DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Research Laboratories, Inc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K935922. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 360 SLX ADVISORY DEFIBRILLATOR?

360 SLX ADVISORY DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Medical Research Laboratories, Inc.. The 510(k) number is K935922.

When did 360 SLX ADVISORY DEFIBRILLATOR receive FDA 510(k) clearance?

360 SLX ADVISORY DEFIBRILLATOR received FDA 510(k) clearance on 1994-12-22, under 510(k) number K935922.

Who is the listed applicant for 360 SLX ADVISORY DEFIBRILLATOR?

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

What is the FDA product code for 360 SLX ADVISORY DEFIBRILLATOR?

The FDA product code for 360 SLX ADVISORY DEFIBRILLATOR is MKJ. This falls under the Dental category.

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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.