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FDA 510(k)

H20- TETHERED OPTION

K-Number: K992291 · 1999-08-06

ApplicantGrass-Telefactor Product Group
Decision Date1999-08-06
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

H20- TETHERED OPTION 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 1999-08-06 under 510(k) number K992291. 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 H20- TETHERED OPTION?

H20- TETHERED OPTION is a medical device that received FDA 510(k) clearance on 1999-08-06. The listed applicant is Grass-Telefactor Product Group. The 510(k) number is K992291.

When did H20- TETHERED OPTION receive FDA 510(k) clearance?

H20- TETHERED OPTION received FDA 510(k) clearance on 1999-08-06, under 510(k) number K992291.

Who is the listed applicant for H20- TETHERED OPTION?

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 H20- TETHERED OPTION?

The FDA product code for H20- TETHERED OPTION is OLV.

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Other records listing Grass-Telefactor Product Group as applicant

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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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