FDA 510(k)

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM

K-Number: K092313 · 2009-11-04

Decision Date2009-11-04

Product CodeMEA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2009-11-04 under 510(k) number K092313. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM?

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-04. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K092313.

When did PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM receive FDA 510(k) clearance?

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM received FDA 510(k) clearance on 2009-11-04, under 510(k) number K092313.

Who is the listed applicant for PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM?

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

What is the FDA product code for PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM?

The FDA product code for PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM is MEA.

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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.