FDA 510(k)

B-D E ML PEN

K-Number: K980755 · 1998-04-02

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1998-04-02

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

B-D E ML PEN is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980755. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-D E ML PEN?

B-D E ML PEN is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K980755.

When did B-D E ML PEN receive FDA 510(k) clearance?

B-D E ML PEN received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980755.

Who is the listed applicant for B-D E ML PEN?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-D E ML PEN?

The FDA product code for B-D E ML PEN is FMF.

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.