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FDA 510(k)

INSTRUMENTARIUM MEGA4 HT

K-Number: K925987 · 1993-05-19

ApplicantInstrumentarium Imaging, Inc.
Decision Date1993-05-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTRUMENTARIUM MEGA4 HT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Imaging, Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K925987. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENTARIUM MEGA4 HT?

INSTRUMENTARIUM MEGA4 HT is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K925987.

When did INSTRUMENTARIUM MEGA4 HT receive FDA 510(k) clearance?

INSTRUMENTARIUM MEGA4 HT received FDA 510(k) clearance on 1993-05-19, under 510(k) number K925987.

Who is the listed applicant for INSTRUMENTARIUM MEGA4 HT?

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

What is the FDA product code for INSTRUMENTARIUM MEGA4 HT?

The FDA product code for INSTRUMENTARIUM MEGA4 HT is LNH.

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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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