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FDA 510(k)

THE WAND

K-Number: K961648 · 1996-07-05

ApplicantSpintech, Inc.
Decision Date1996-07-05
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE WAND is the device name listed in this FDA 510(k) record. The listed applicant is Spintech, Inc.. It received FDA 510(k) clearance on 1996-07-05 under 510(k) number K961648. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE WAND?

THE WAND is a medical device that received FDA 510(k) clearance on 1996-07-05. The listed applicant is Spintech, Inc.. The 510(k) number is K961648.

When did THE WAND receive FDA 510(k) clearance?

THE WAND received FDA 510(k) clearance on 1996-07-05, under 510(k) number K961648.

Who is the listed applicant for THE WAND?

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

What is the FDA product code for THE WAND?

The FDA product code for THE WAND is EJI.

Other records listing Spintech, Inc. 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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Related Devices (Code: EJI)

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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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