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FDA 510(k)

INFU BOX TYPE 0412A

K-Number: K120860 · 2012-05-08

ApplicantMedical Rescue Equipment Holding AS
Decision Date2012-05-08
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFU BOX TYPE 0412A is the device name listed in this FDA 510(k) record. The listed applicant is Medical Rescue Equipment Holding AS. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K120860. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFU BOX TYPE 0412A?

INFU BOX TYPE 0412A is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Medical Rescue Equipment Holding AS. The 510(k) number is K120860.

When did INFU BOX TYPE 0412A receive FDA 510(k) clearance?

INFU BOX TYPE 0412A received FDA 510(k) clearance on 2012-05-08, under 510(k) number K120860.

Who is the listed applicant for INFU BOX TYPE 0412A?

The FDA 510(k) record lists Medical Rescue Equipment Holding AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFU BOX TYPE 0412A?

The FDA product code for INFU BOX TYPE 0412A is LGZ.

Related Devices (Code: LGZ)

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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