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FDA 510(k)

BETA I PROGRAMMABLE INFUSION PUMP

K-Number: K831897 · 1983-08-12

ApplicantOrange Medical Instruments, Inc.
Decision Date1983-08-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BETA I PROGRAMMABLE INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Orange Medical Instruments, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831897. 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 BETA I PROGRAMMABLE INFUSION PUMP?

BETA I PROGRAMMABLE INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Orange Medical Instruments, Inc.. The 510(k) number is K831897.

When did BETA I PROGRAMMABLE INFUSION PUMP receive FDA 510(k) clearance?

BETA I PROGRAMMABLE INFUSION PUMP received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831897.

Who is the listed applicant for BETA I PROGRAMMABLE INFUSION PUMP?

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

What is the FDA product code for BETA I PROGRAMMABLE INFUSION PUMP?

The FDA product code for BETA I PROGRAMMABLE INFUSION PUMP is FRN.

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Other records listing Orange Medical Instruments, 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.

K860808CONTINUCATHK851822BETA SCAN TRENDS METERK844796MICRO-BETA U100 SYRINGEK843882TRENDS LANCETK841369BETA SCAN DRYSTIXK833705BETAJECT BD U100

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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.

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