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FDA 510(k)

TBD

K-Number: K963026 · 1996-10-28

ApplicantAcu Med, Inc.
Decision Date1996-10-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TBD is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1996-10-28 under 510(k) number K963026. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBD?

TBD is a medical device that received FDA 510(k) clearance on 1996-10-28. The listed applicant is Acu Med, Inc.. The 510(k) number is K963026.

When did TBD receive FDA 510(k) clearance?

TBD received FDA 510(k) clearance on 1996-10-28, under 510(k) number K963026.

Who is the listed applicant for TBD?

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

What is the FDA product code for TBD?

The FDA product code for TBD is HSB.

Other records listing Acu Med, 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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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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