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FDA 510(k)

PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET

K-Number: K972839 · 1997-12-17

ApplicantGlobe Ent., Inc.
Decision Date1997-12-17
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Globe Ent., Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K972839. 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 PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET?

PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Globe Ent., Inc.. The 510(k) number is K972839.

When did PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET receive FDA 510(k) clearance?

PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET received FDA 510(k) clearance on 1997-12-17, under 510(k) number K972839.

Who is the listed applicant for PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET?

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

What is the FDA product code for PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET?

The FDA product code for PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET is FPA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Globe Ent., Inc. 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.

K972854PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARYK972843PROTOS BLOOD TRANSFUSION SETK892623PATIENT EXAMINATION GLOVES (LATEX)K884622SURGICAL GLOVES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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