FDA 510(k)

MODIFICATION TO PORTABLE INTENSIVE CARE UNIT

K-Number: K983307 · 1998-11-20

ApplicantMedical Research Laboratories, Inc.

Decision Date1998-11-20

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PORTABLE INTENSIVE CARE UNIT 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 1998-11-20 under 510(k) number K983307. 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 MODIFICATION TO PORTABLE INTENSIVE CARE UNIT?

MODIFICATION TO PORTABLE INTENSIVE CARE UNIT is a medical device that received FDA 510(k) clearance on 1998-11-20. The listed applicant is Medical Research Laboratories, Inc.. The 510(k) number is K983307.

When did MODIFICATION TO PORTABLE INTENSIVE CARE UNIT receive FDA 510(k) clearance?

MODIFICATION TO PORTABLE INTENSIVE CARE UNIT received FDA 510(k) clearance on 1998-11-20, under 510(k) number K983307.

Who is the listed applicant for MODIFICATION TO PORTABLE INTENSIVE CARE UNIT?

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 MODIFICATION TO PORTABLE INTENSIVE CARE UNIT?

The FDA product code for MODIFICATION TO PORTABLE INTENSIVE CARE UNIT 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.