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FDA 510(k)

ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP

K-Number: K850792 · 1985-11-13

ApplicantJanssen Pharmaceutica, Inc.
Decision Date1985-11-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Janssen Pharmaceutica, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K850792. 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 ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP?

ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Janssen Pharmaceutica, Inc.. The 510(k) number is K850792.

When did ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP receive FDA 510(k) clearance?

ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP received FDA 510(k) clearance on 1985-11-13, under 510(k) number K850792.

Who is the listed applicant for ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP?

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

What is the FDA product code for ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP?

The FDA product code for ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP is FRN.

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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.

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