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FDA 510(k)

SUPREME II CONTROL SOLUTIONS

K-Number: K983432 · 1998-12-17

ApplicantChronimed, Inc.
Decision Date1998-12-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUPREME II CONTROL SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Chronimed, Inc.. It received FDA 510(k) clearance on 1998-12-17 under 510(k) number K983432. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPREME II CONTROL SOLUTIONS?

SUPREME II CONTROL SOLUTIONS is a medical device that received FDA 510(k) clearance on 1998-12-17. The listed applicant is Chronimed, Inc.. The 510(k) number is K983432.

When did SUPREME II CONTROL SOLUTIONS receive FDA 510(k) clearance?

SUPREME II CONTROL SOLUTIONS received FDA 510(k) clearance on 1998-12-17, under 510(k) number K983432.

Who is the listed applicant for SUPREME II CONTROL SOLUTIONS?

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

What is the FDA product code for SUPREME II CONTROL SOLUTIONS?

The FDA product code for SUPREME II CONTROL SOLUTIONS is JJX.

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Other records listing Chronimed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JJX)

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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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