FDA 510(k)

PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200

K-Number: K032831 · 2004-08-31

Decision Date2004-08-31

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2004-08-31 under 510(k) number K032831. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200?

PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 is a medical device that received FDA 510(k) clearance on 2004-08-31. The listed applicant is Conmed Corporation. The 510(k) number is K032831.

When did PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 receive FDA 510(k) clearance?

PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 received FDA 510(k) clearance on 2004-08-31, under 510(k) number K032831.

Who is the listed applicant for PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200?

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

What is the FDA product code for PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200?

The FDA product code for PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 is DQA.

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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.