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FDA 510(k)

SOFTINJECT

K-Number: K991680 · 1999-06-03

ApplicantAndrosystems Srl
Decision Date1999-06-03
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOFTINJECT is the device name listed in this FDA 510(k) record. The listed applicant is Androsystems Srl. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K991680. 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 SOFTINJECT?

SOFTINJECT is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Androsystems Srl. The 510(k) number is K991680.

When did SOFTINJECT receive FDA 510(k) clearance?

SOFTINJECT received FDA 510(k) clearance on 1999-06-03, under 510(k) number K991680.

Who is the listed applicant for SOFTINJECT?

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

What is the FDA product code for SOFTINJECT?

The FDA product code for SOFTINJECT 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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