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FDA 510(k)

OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR

K-Number: K881004 · 1988-05-12

ApplicantKeymed, Inc.
Decision Date1988-05-12
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1988-05-12 under 510(k) number K881004. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR?

OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR is a medical device that received FDA 510(k) clearance on 1988-05-12. The listed applicant is Keymed, Inc.. The 510(k) number is K881004.

When did OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR receive FDA 510(k) clearance?

OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR received FDA 510(k) clearance on 1988-05-12, under 510(k) number K881004.

Who is the listed applicant for OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR?

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-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR?

The FDA product code for OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR is FCX.

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Other records listing Keymed, Inc. as applicant

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Related Devices (Code: FCX)

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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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