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FDA 510(k)

PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST

K-Number: K082237 · 2008-10-09

ApplicantMallinckrodt Developpement France
Decision Date2008-10-09
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Developpement France. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K082237. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST?

PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Mallinckrodt Developpement France. The 510(k) number is K082237.

When did PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST receive FDA 510(k) clearance?

PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST received FDA 510(k) clearance on 2008-10-09, under 510(k) number K082237.

Who is the listed applicant for PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST?

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

What is the FDA product code for PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST?

The FDA product code for PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST is BZD.

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Related Devices (Code: BZD)

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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