FDA 510(k)

H2O

K-Number: K974587 · 1998-03-09

Decision Date1998-03-09

Product CodeOLV

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

H2O is the device name listed in this FDA 510(k) record. The listed applicant is Grass-Telefactor Product Group. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K974587. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H2O?

H2O is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Grass-Telefactor Product Group. The 510(k) number is K974587.

When did H2O receive FDA 510(k) clearance?

H2O received FDA 510(k) clearance on 1998-03-09, under 510(k) number K974587.

Who is the listed applicant for H2O?

The FDA 510(k) record lists Grass-Telefactor Product Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H2O?

The FDA product code for H2O is OLV.

Other records listing Grass-Telefactor Product Group 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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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.