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FDA 510(k)

FLUID MANAGEMENT SYSTEM (MODIFIED)

K-Number: K860969 · 1986-05-06

ApplicantHaemonetics Corp.
Decision Date1986-05-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUID MANAGEMENT SYSTEM (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 1986-05-06 under 510(k) number K860969. 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 FLUID MANAGEMENT SYSTEM (MODIFIED)?

FLUID MANAGEMENT SYSTEM (MODIFIED) is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Haemonetics Corp.. The 510(k) number is K860969.

When did FLUID MANAGEMENT SYSTEM (MODIFIED) receive FDA 510(k) clearance?

FLUID MANAGEMENT SYSTEM (MODIFIED) received FDA 510(k) clearance on 1986-05-06, under 510(k) number K860969.

Who is the listed applicant for FLUID MANAGEMENT SYSTEM (MODIFIED)?

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

What is the FDA product code for FLUID MANAGEMENT SYSTEM (MODIFIED)?

The FDA product code for FLUID MANAGEMENT SYSTEM (MODIFIED) is FRN.

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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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