FDA 510(k)

SCEPTRE-VS

K-Number: K021314 · 2002-07-02

ApplicantHitachi Medical Systems America, Inc.

Decision Date2002-07-02

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SCEPTRE-VS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021314. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCEPTRE-VS?

SCEPTRE-VS is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K021314.

When did SCEPTRE-VS receive FDA 510(k) clearance?

SCEPTRE-VS received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021314.

Who is the listed applicant for SCEPTRE-VS?

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

What is the FDA product code for SCEPTRE-VS?

The FDA product code for SCEPTRE-VS is LLZ.

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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.