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FDA 510(k)

PORTABLE INTENSIVE CARE UNIT

K-Number: K012766 · 2002-01-23

ApplicantMedical Research Laboratories, Inc.
Decision Date2002-01-23
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

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 2002-01-23 under 510(k) number K012766. 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 - Subject to Tracking Reg..

Frequently Asked Questions

What is the PORTABLE INTENSIVE CARE UNIT?

PORTABLE INTENSIVE CARE UNIT is a medical device that received FDA 510(k) clearance on 2002-01-23. The listed applicant is Medical Research Laboratories, Inc.. The 510(k) number is K012766.

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

PORTABLE INTENSIVE CARE UNIT received FDA 510(k) clearance on 2002-01-23, under 510(k) number K012766.

Who is the listed applicant for 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 PORTABLE INTENSIVE CARE UNIT?

The FDA product code for PORTABLE INTENSIVE CARE UNIT is MKJ. This falls under the Dental category.

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Other records listing Medical Research Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021168JUMP START, MODEL 970300K012030PORTABLE INTENSIVE CARE UNITK010207PORTABLE INSTENSIVE CARE UNITK002232AEDEFIBRILLATORK000712PORTABLE INTENSIVE CARE UNIT, MODEL PICK983307MODIFICATION TO PORTABLE INTENSIVE CARE UNIT

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Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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