FDA 510(k)

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113

K-Number: K031566 · 2003-08-19

Decision Date2003-08-19

Product CodeMEA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2003-08-19 under 510(k) number K031566. 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 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113?

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 is a medical device that received FDA 510(k) clearance on 2003-08-19. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K031566.

When did SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 receive FDA 510(k) clearance?

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 received FDA 510(k) clearance on 2003-08-19, under 510(k) number K031566.

Who is the listed applicant for SYNDEO PCA SYRINGE PUMP, MODEL 2L3113?

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

What is the FDA product code for SYNDEO PCA SYRINGE PUMP, MODEL 2L3113?

The FDA product code for SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 is MEA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.