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)

OPEN-LOOP INSULIN DELIVERY SYSTEM

K-Number: K801704 · 1980-08-13

ApplicantDelta Medical Industries
Decision Date1980-08-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPEN-LOOP INSULIN DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Delta Medical Industries. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801704. 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 OPEN-LOOP INSULIN DELIVERY SYSTEM?

OPEN-LOOP INSULIN DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Delta Medical Industries. The 510(k) number is K801704.

When did OPEN-LOOP INSULIN DELIVERY SYSTEM receive FDA 510(k) clearance?

OPEN-LOOP INSULIN DELIVERY SYSTEM received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801704.

Who is the listed applicant for OPEN-LOOP INSULIN DELIVERY SYSTEM?

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

What is the FDA product code for OPEN-LOOP INSULIN DELIVERY SYSTEM?

The FDA product code for OPEN-LOOP INSULIN DELIVERY SYSTEM 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 Delta Medical Industries 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.

K833884ISOTEC DISPOS. PRESSURE TRANSDUCERK840253ONE-WAY AIR VALVEK832470INFUSION PUMPK830389ACCU-RYNGE PUMP SP-250K831750PM-3K822761DELIVERY TUBE SET #2226

View all 27 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.

↑