FDA 510(k)

INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K

K-Number: K002739 · 2000-09-11

Decision Date2000-09-11

Product CodeMEA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K 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 2000-09-11 under 510(k) number K002739. 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 INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K?

INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K is a medical device that received FDA 510(k) clearance on 2000-09-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K002739.

When did INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K receive FDA 510(k) clearance?

INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K received FDA 510(k) clearance on 2000-09-11, under 510(k) number K002739.

Who is the listed applicant for INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K?

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 INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K?

The FDA product code for INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K 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.