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FDA 510(k)

OBI

K-Number: K083669 · 2009-06-08

ApplicantEuroteknika
Decision Date2009-06-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OBI is the device name listed in this FDA 510(k) record. The listed applicant is Euroteknika. It received FDA 510(k) clearance on 2009-06-08 under 510(k) number K083669. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBI?

OBI is a medical device that received FDA 510(k) clearance on 2009-06-08. The listed applicant is Euroteknika. The 510(k) number is K083669.

When did OBI receive FDA 510(k) clearance?

OBI received FDA 510(k) clearance on 2009-06-08, under 510(k) number K083669.

Who is the listed applicant for OBI?

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

What is the FDA product code for OBI?

The FDA product code for OBI is DZE.

Related PubMed Literature

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.

PMID: 42397807Borrowing from the cancer playbook: a master protocol basket trial for hard-to-heal wound therapeutics targeting shared pathobiology.Journal of wound care ()PMID: 41450770Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?Journal of law and the biosciences ()PMID: 40801347Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives.Critical reviews in clinical laboratory sciences ()PMID: 33070659Strategies for antimicrobial peptide coatings on medical devices: a review and regulatory science perspective.Critical reviews in biotechnology ()

Other records listing Euroteknika as applicant

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.

K232383iPhysio® SystemK083670UNIVERSAL, AESTHETICA, NATEA, NATURA

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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