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FDA 510(k)

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)

K-Number: K032393 · 2003-09-12

ApplicantElcam Medical Acal
Decision Date2003-09-12
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) 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 2003-09-12 under 510(k) number K032393. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)?

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) is a medical device that received FDA 510(k) clearance on 2003-09-12. The listed applicant is Elcam Medical Acal. The 510(k) number is K032393.

When did INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) receive FDA 510(k) clearance?

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) received FDA 510(k) clearance on 2003-09-12, under 510(k) number K032393.

Who is the listed applicant for INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)?

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 INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)?

The FDA product code for INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) is FMG.

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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: FMG)

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.

K242255Qitexio® 4-Way Stopcock (QIT014)MedexK223499Three Way Stop CockM/S Romsons InternationalK223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare CorporationK211204SafePort(TM) Manifold (or Stopcock)Elcam Medical AcalK210516Clicky CrossYomura Technologies, Inc.K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLC

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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