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FDA 510(k)

HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE

K-Number: K913264 · 1991-11-01

ApplicantMallinckrodt Group, Inc.
Decision Date1991-11-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE 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 1991-11-01 under 510(k) number K913264. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE?

HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is Mallinckrodt Group, Inc.. The 510(k) number is K913264.

When did HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE receive FDA 510(k) clearance?

HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE received FDA 510(k) clearance on 1991-11-01, under 510(k) number K913264.

Who is the listed applicant for HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE?

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 HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE?

The FDA product code for HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE is LLZ.

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Other records listing Mallinckrodt Group, Inc. as applicant

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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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