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FDA 510(k)

MODELS: 52-01-0, 52-01-1

K-Number: K811110 · 1981-06-11

ApplicantY
Decision Date1981-06-11
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODELS: 52-01-0, 52-01-1 is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1981-06-11 under 510(k) number K811110. 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 MODELS: 52-01-0, 52-01-1?

MODELS: 52-01-0, 52-01-1 is a medical device that received FDA 510(k) clearance on 1981-06-11. The listed applicant is Y. The 510(k) number is K811110.

When did MODELS: 52-01-0, 52-01-1 receive FDA 510(k) clearance?

MODELS: 52-01-0, 52-01-1 received FDA 510(k) clearance on 1981-06-11, under 510(k) number K811110.

Who is the listed applicant for MODELS: 52-01-0, 52-01-1?

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

What is the FDA product code for MODELS: 52-01-0, 52-01-1?

The FDA product code for MODELS: 52-01-0, 52-01-1 is FPA.

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Other records listing Y 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.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

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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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