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)

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00

K-Number: K991437 · 1999-08-30

ApplicantWells Johnson Co.
Decision Date1999-08-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 is the device name listed in this FDA 510(k) record. The listed applicant is Wells Johnson Co.. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K991437. 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 WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00?

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Wells Johnson Co.. The 510(k) number is K991437.

When did WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 receive FDA 510(k) clearance?

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 received FDA 510(k) clearance on 1999-08-30, under 510(k) number K991437.

Who is the listed applicant for WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00?

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

What is the FDA product code for WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00?

The FDA product code for WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 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 Wells Johnson Co. 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.

K984448BIRCOLL BALLOON DISSECTORK971580UAS ULTRASONIC ASPIRATOR SYSTEMK945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945500WELLS JOHNSON FIXATION SYSTEMK951519WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

View all 15 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.

↑