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FDA 510(k)

DORIPENEM 10UG BBL SENSI-DISC

K-Number: K080998 · 2008-05-12

ApplicantBecton, Dickinson & CO
Decision Date2008-05-12
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DORIPENEM 10UG BBL SENSI-DISC is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2008-05-12 under 510(k) number K080998. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORIPENEM 10UG BBL SENSI-DISC?

DORIPENEM 10UG BBL SENSI-DISC is a medical device that received FDA 510(k) clearance on 2008-05-12. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K080998.

When did DORIPENEM 10UG BBL SENSI-DISC receive FDA 510(k) clearance?

DORIPENEM 10UG BBL SENSI-DISC received FDA 510(k) clearance on 2008-05-12, under 510(k) number K080998.

Who is the listed applicant for DORIPENEM 10UG BBL SENSI-DISC?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORIPENEM 10UG BBL SENSI-DISC?

The FDA product code for DORIPENEM 10UG BBL SENSI-DISC is JTN.

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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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