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FDA 510(k)

FLEXI-Q DV AND DVR AUTO-INJECTORS

K-Number: K111467 · 2012-02-09

ApplicantElcam Medical Acal
Decision Date2012-02-09
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLEXI-Q DV AND DVR AUTO-INJECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2012-02-09 under 510(k) number K111467. 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 FLEXI-Q DV AND DVR AUTO-INJECTORS?

FLEXI-Q DV AND DVR AUTO-INJECTORS is a medical device that received FDA 510(k) clearance on 2012-02-09. The listed applicant is Elcam Medical Acal. The 510(k) number is K111467.

When did FLEXI-Q DV AND DVR AUTO-INJECTORS receive FDA 510(k) clearance?

FLEXI-Q DV AND DVR AUTO-INJECTORS received FDA 510(k) clearance on 2012-02-09, under 510(k) number K111467.

Who is the listed applicant for FLEXI-Q DV AND DVR AUTO-INJECTORS?

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

What is the FDA product code for FLEXI-Q DV AND DVR AUTO-INJECTORS?

The FDA product code for FLEXI-Q DV AND DVR AUTO-INJECTORS is KZH.

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Other records listing Elcam Medical Acal 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.

K231900A-TAP (previously called Arthrotap)K211204SafePort(TM) Manifold (or Stopcock)K190489Elcam Stopcocks and ManifoldsK123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLDK120253ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)

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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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