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FDA 510(k)

HYDRA VIEW IMAGING SYSTEM

K-Number: K901323 · 1990-04-25

ApplicantMallinckrodt Group, Inc.
Decision Date1990-04-25
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HYDRA VIEW IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Group, Inc.. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K901323. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRA VIEW IMAGING SYSTEM?

HYDRA VIEW IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Mallinckrodt Group, Inc.. The 510(k) number is K901323.

When did HYDRA VIEW IMAGING SYSTEM receive FDA 510(k) clearance?

HYDRA VIEW IMAGING SYSTEM received FDA 510(k) clearance on 1990-04-25, under 510(k) number K901323.

Who is the listed applicant for HYDRA VIEW IMAGING SYSTEM?

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

What is the FDA product code for HYDRA VIEW IMAGING SYSTEM?

The FDA product code for HYDRA VIEW IMAGING SYSTEM is JAA.

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Other records listing Mallinckrodt Group, Inc. as applicant

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Related Devices (Code: JAA)

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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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