FDA 510(k)

VESPHENE II

K-Number: K931573 · 1994-05-16

Decision Date1994-05-16

Product CodeLRJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VESPHENE II is the device name listed in this FDA 510(k) record. The listed applicant is Calgon Vestal Div.. It received FDA 510(k) clearance on 1994-05-16 under 510(k) number K931573. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESPHENE II?

VESPHENE II is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Calgon Vestal Div.. The 510(k) number is K931573.

When did VESPHENE II receive FDA 510(k) clearance?

VESPHENE II received FDA 510(k) clearance on 1994-05-16, under 510(k) number K931573.

Who is the listed applicant for VESPHENE II?

The FDA 510(k) record lists Calgon Vestal Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VESPHENE II?

The FDA product code for VESPHENE II is LRJ. This falls under the Clinical Lab category.

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Other records listing Calgon Vestal Div. as applicant

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Related Devices (Code: LRJ)

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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.