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FDA 510(k)

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP

K-Number: K023205 · 2003-04-24

ApplicantBiotronik, Inc.
Decision Date2003-04-24
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2003-04-24 under 510(k) number K023205. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP?

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP is a medical device that received FDA 510(k) clearance on 2003-04-24. The listed applicant is Biotronik, Inc.. The 510(k) number is K023205.

When did ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP receive FDA 510(k) clearance?

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP received FDA 510(k) clearance on 2003-04-24, under 510(k) number K023205.

Who is the listed applicant for ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP?

The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP?

The FDA product code for ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP is DTB.

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Related Devices (Code: DTB)

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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