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FDA 510(k)

OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1

K-Number: K100803 · 2010-04-22

ApplicantKeymed, Inc.
Decision Date2010-04-22
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K100803. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1?

OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Keymed, Inc.. The 510(k) number is K100803.

When did OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 receive FDA 510(k) clearance?

OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 received FDA 510(k) clearance on 2010-04-22, under 510(k) number K100803.

Who is the listed applicant for OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1?

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

What is the FDA product code for OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1?

The FDA product code for OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 is FEQ.

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Other records listing Keymed, Inc. as applicant

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Related Devices (Code: FEQ)

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.

K220395EndoGator Endoscopy Irrigation TubingSTERIS CorporationK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, 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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