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FDA 510(k)

DISPOSABLE MANIFOLD SET

K-Number: K832657 · 1983-11-07

ApplicantMallinckrodt Critical Care
Decision Date1983-11-07
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MANIFOLD SET is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K832657. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE MANIFOLD SET?

DISPOSABLE MANIFOLD SET is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K832657.

When did DISPOSABLE MANIFOLD SET receive FDA 510(k) clearance?

DISPOSABLE MANIFOLD SET received FDA 510(k) clearance on 1983-11-07, under 510(k) number K832657.

Who is the listed applicant for DISPOSABLE MANIFOLD SET?

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

What is the FDA product code for DISPOSABLE MANIFOLD SET?

The FDA product code for DISPOSABLE MANIFOLD SET is DRS.

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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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