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FDA 510(k)

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

K-Number: K002138 · 2000-08-29

ApplicantMaersk Medical A/S
Decision Date2000-08-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 is the device name listed in this FDA 510(k) record. The listed applicant is Maersk Medical A/S. It received FDA 510(k) clearance on 2000-08-29 under 510(k) number K002138. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380?

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 is a medical device that received FDA 510(k) clearance on 2000-08-29. The listed applicant is Maersk Medical A/S. The 510(k) number is K002138.

When did PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 receive FDA 510(k) clearance?

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 received FDA 510(k) clearance on 2000-08-29, under 510(k) number K002138.

Who is the listed applicant for PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380?

The FDA 510(k) record lists Maersk Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380?

The FDA product code for PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 is FPA.

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Other records listing Maersk Medical A/S as applicant

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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