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FDA 510(k)

AMBULATORY MARK III INFUSION DEVICE

K-Number: K830656 · 1983-08-16

ApplicantWindsor Medical, Inc.
Decision Date1983-08-16
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBULATORY MARK III INFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Medical, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K830656. 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 AMBULATORY MARK III INFUSION DEVICE?

AMBULATORY MARK III INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Windsor Medical, Inc.. The 510(k) number is K830656.

When did AMBULATORY MARK III INFUSION DEVICE receive FDA 510(k) clearance?

AMBULATORY MARK III INFUSION DEVICE received FDA 510(k) clearance on 1983-08-16, under 510(k) number K830656.

Who is the listed applicant for AMBULATORY MARK III INFUSION DEVICE?

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

What is the FDA product code for AMBULATORY MARK III INFUSION DEVICE?

The FDA product code for AMBULATORY MARK III INFUSION DEVICE is FRN.

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Other records listing Windsor Medical, 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.

K841481WINDSOR MEDICAL MODEL 50-00002K832606WINDSOR MEDICAL VARIOUS MODELSK832641WINDSOR MEDICAL MODEL 52K830657AMBULATORY MARK XI DRUG INFUSION DEV-K830544WINDSOR MEDICAL, INC. 50-01-028K830317INFUSION PUMP ACCESS. #60-01-5

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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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