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FDA 510(k)

CHARTER MEDICAL NEONATAL SYRINGE SET

K-Number: K000685 · 2000-08-15

ApplicantCharter Medical, Ltd.
Decision Date2000-08-15
Product CodeBRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHARTER MEDICAL NEONATAL SYRINGE SET is the device name listed in this FDA 510(k) record. The listed applicant is Charter Medical, Ltd.. It received FDA 510(k) clearance on 2000-08-15 under 510(k) number K000685. The device is classified under product code BRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARTER MEDICAL NEONATAL SYRINGE SET?

CHARTER MEDICAL NEONATAL SYRINGE SET is a medical device that received FDA 510(k) clearance on 2000-08-15. The listed applicant is Charter Medical, Ltd.. The 510(k) number is K000685.

When did CHARTER MEDICAL NEONATAL SYRINGE SET receive FDA 510(k) clearance?

CHARTER MEDICAL NEONATAL SYRINGE SET received FDA 510(k) clearance on 2000-08-15, under 510(k) number K000685.

Who is the listed applicant for CHARTER MEDICAL NEONATAL SYRINGE SET?

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

What is the FDA product code for CHARTER MEDICAL NEONATAL SYRINGE SET?

The FDA product code for CHARTER MEDICAL NEONATAL SYRINGE SET is BRZ.

Related Clinical Trials

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Other records listing Charter Medical, Ltd. 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.

K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)

Related Devices (Code: BRZ)

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.

K220558Blood Administration SetsBaxter Healthcare CorporationK210335Blood Administration SetBaxter Healthcare CorporationK132905200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTERArteriocyte Medical Systems, Inc.K083349BLOOD TRANSFUSION SETShan Dong Wei Gao Group Medical Polymer ProductsK073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.A

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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