Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER

K-Number: K863532 · 1987-01-14

ApplicantParker Hannifin Corp.
Decision Date1987-01-14
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Parker Hannifin Corp.. It received FDA 510(k) clearance on 1987-01-14 under 510(k) number K863532. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER?

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER is a medical device that received FDA 510(k) clearance on 1987-01-14. The listed applicant is Parker Hannifin Corp.. The 510(k) number is K863532.

When did MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER receive FDA 510(k) clearance?

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER received FDA 510(k) clearance on 1987-01-14, under 510(k) number K863532.

Who is the listed applicant for MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER?

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

What is the FDA product code for MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER?

The FDA product code for MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER is FRN.

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 Parker Hannifin Corp. 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.

K161731Cleveland Multiport Ventricular Catheter SetK897086PARKER AMBULATORY MEDICATION INFUSION PUMP 2004K834461INFUSION PUMP PRIMERK833723MODEL 2000 AMBULATORY MED. INFUSERK831402PRESSURE MONITOR & CONTROL UNIT APC-02AK831747PLASMA THERAPY TUBESET-E100 SERIES

View all 8 devices →

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.

↑