FDA 510(k)

3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000

K-Number: K980089 · 1998-03-24

Decision Date1998-03-24

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Valley West, Inc.. It received FDA 510(k) clearance on 1998-03-24 under 510(k) number K980089. 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 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000?

3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 is a medical device that received FDA 510(k) clearance on 1998-03-24. The listed applicant is Valley West, Inc.. The 510(k) number is K980089.

When did 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 receive FDA 510(k) clearance?

3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 received FDA 510(k) clearance on 1998-03-24, under 510(k) number K980089.

Who is the listed applicant for 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000?

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

What is the FDA product code for 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000?

The FDA product code for 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 is FRN.

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Other records listing Valley West, Inc. as applicant

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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.