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FDA 510(k)

MEDSAFE SYSTEM INSERTER

K-Number: K032848 · 2004-04-12

ApplicantMedsolve Technologies, LLC
Decision Date2004-04-12
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDSAFE SYSTEM INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Medsolve Technologies, LLC. It received FDA 510(k) clearance on 2004-04-12 under 510(k) number K032848. 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 MEDSAFE SYSTEM INSERTER?

MEDSAFE SYSTEM INSERTER is a medical device that received FDA 510(k) clearance on 2004-04-12. The listed applicant is Medsolve Technologies, LLC. The 510(k) number is K032848.

When did MEDSAFE SYSTEM INSERTER receive FDA 510(k) clearance?

MEDSAFE SYSTEM INSERTER received FDA 510(k) clearance on 2004-04-12, under 510(k) number K032848.

Who is the listed applicant for MEDSAFE SYSTEM INSERTER?

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

What is the FDA product code for MEDSAFE SYSTEM INSERTER?

The FDA product code for MEDSAFE SYSTEM INSERTER is KZH.

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Related Devices (Code: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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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