FDA 510(k)

1000 PRESSURE INFUSION SIGMACON 1000

K-Number: K990447 · 1999-05-12

Decision Date1999-05-12

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

1000 PRESSURE INFUSION SIGMACON 1000 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 1999-05-12 under 510(k) number K990447. 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 1000 PRESSURE INFUSION SIGMACON 1000?

1000 PRESSURE INFUSION SIGMACON 1000 is a medical device that received FDA 510(k) clearance on 1999-05-12. The listed applicant is Valley West, Inc.. The 510(k) number is K990447.

When did 1000 PRESSURE INFUSION SIGMACON 1000 receive FDA 510(k) clearance?

1000 PRESSURE INFUSION SIGMACON 1000 received FDA 510(k) clearance on 1999-05-12, under 510(k) number K990447.

Who is the listed applicant for 1000 PRESSURE INFUSION SIGMACON 1000?

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 1000 PRESSURE INFUSION SIGMACON 1000?

The FDA product code for 1000 PRESSURE INFUSION SIGMACON 1000 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.