FDA 510(k)

QUANTROLS IM

K-Number: K771941 · 1977-11-02

Decision Date1977-11-02

Product Code

DecisionSubstantially Equivalent

Device Summary

QUANTROLS IM is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1977-11-02 under 510(k) number K771941. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTROLS IM?

QUANTROLS IM is a medical device that received FDA 510(k) clearance on 1977-11-02. The listed applicant is Organon, Inc.. The 510(k) number is K771941.

When did QUANTROLS IM receive FDA 510(k) clearance?

QUANTROLS IM received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771941.

Who is the listed applicant for QUANTROLS IM?

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

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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.