FDA 510(k)

HVGS 9000

K-Number: K926084 · 1994-03-14

Decision Date1994-03-14

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HVGS 9000 is the device name listed in this FDA 510(k) record. The listed applicant is Shevlin Medical, Inc.. It received FDA 510(k) clearance on 1994-03-14 under 510(k) number K926084. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HVGS 9000?

HVGS 9000 is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Shevlin Medical, Inc.. The 510(k) number is K926084.

When did HVGS 9000 receive FDA 510(k) clearance?

HVGS 9000 received FDA 510(k) clearance on 1994-03-14, under 510(k) number K926084.

Who is the listed applicant for HVGS 9000?

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

What is the FDA product code for HVGS 9000?

The FDA product code for HVGS 9000 is IPF.

Related Devices (Code: IPF)

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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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.