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FDA 510(k)

CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400

K-Number: K982838 · 1998-11-04

ApplicantSims Deltec, Inc.
Decision Date1998-11-04
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K982838. 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 CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400?

CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K982838.

When did CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 receive FDA 510(k) clearance?

CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 received FDA 510(k) clearance on 1998-11-04, under 510(k) number K982838.

Who is the listed applicant for CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400?

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

What is the FDA product code for CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400?

The FDA product code for CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 is FRN.

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Other records listing Sims Deltec, Inc. as applicant

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Related Devices (Code: FRN)

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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.

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