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FDA 510(k)

AMP 80/2 OUTFLOW MONITOR MODIFICATION

K-Number: K823827 · 1983-03-17

ApplicantAmerican Medical Products, Inc.
Decision Date1983-03-17
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMP 80/2 OUTFLOW MONITOR MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Products, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K823827. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMP 80/2 OUTFLOW MONITOR MODIFICATION?

AMP 80/2 OUTFLOW MONITOR MODIFICATION is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is American Medical Products, Inc.. The 510(k) number is K823827.

When did AMP 80/2 OUTFLOW MONITOR MODIFICATION receive FDA 510(k) clearance?

AMP 80/2 OUTFLOW MONITOR MODIFICATION received FDA 510(k) clearance on 1983-03-17, under 510(k) number K823827.

Who is the listed applicant for AMP 80/2 OUTFLOW MONITOR MODIFICATION?

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

What is the FDA product code for AMP 80/2 OUTFLOW MONITOR MODIFICATION?

The FDA product code for AMP 80/2 OUTFLOW MONITOR MODIFICATION is FKX.

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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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