FDA 510(k)

DAI-R

K-Number: K060141 · 2006-06-12

Decision Date2006-06-12

Product CodeKZH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DAI-R is the device name listed in this FDA 510(k) record. The listed applicant is Shl Medical, USA. It received FDA 510(k) clearance on 2006-06-12 under 510(k) number K060141. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAI-R?

DAI-R is a medical device that received FDA 510(k) clearance on 2006-06-12. The listed applicant is Shl Medical, USA. The 510(k) number is K060141.

When did DAI-R receive FDA 510(k) clearance?

DAI-R received FDA 510(k) clearance on 2006-06-12, under 510(k) number K060141.

Who is the listed applicant for DAI-R?

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

What is the FDA product code for DAI-R?

The FDA product code for DAI-R is KZH.

Other records listing Shl Medical, USA 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.

K050434SHL DISPOSABLE AUTOINJECTOR

Related Devices (Code: KZH)

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies Corporation K163400Orbit InserterYpsomed AG K160860MiniMed Quick-serterMedtronic Minimed K124026LOBSTER AUTO-INJECTORScandinavian Health Limited K122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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.