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FDA 510(k)

OXYPULSE EOC I, EOC II & EOC R

K-Number: K955129 · 1996-02-16

ApplicantEagle Medical Equipment Co.
Decision Date1996-02-16
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYPULSE EOC I, EOC II & EOC R is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Medical Equipment Co.. It received FDA 510(k) clearance on 1996-02-16 under 510(k) number K955129. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYPULSE EOC I, EOC II & EOC R?

OXYPULSE EOC I, EOC II & EOC R is a medical device that received FDA 510(k) clearance on 1996-02-16. The listed applicant is Eagle Medical Equipment Co.. The 510(k) number is K955129.

When did OXYPULSE EOC I, EOC II & EOC R receive FDA 510(k) clearance?

OXYPULSE EOC I, EOC II & EOC R received FDA 510(k) clearance on 1996-02-16, under 510(k) number K955129.

Who is the listed applicant for OXYPULSE EOC I, EOC II & EOC R?

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

What is the FDA product code for OXYPULSE EOC I, EOC II & EOC R?

The FDA product code for OXYPULSE EOC I, EOC II & EOC R is NFB.

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.

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Other records listing Eagle Medical Equipment 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.

K062724ACCUPULSE PULSE OXIMETERK831819OXYGEN CONCENTRATOR RESPIRATORY SUPPOR

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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