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FDA 510(k)

DELTA 32 AND DELTA 32 TACT

K-Number: K002472 · 2000-11-29

ApplicantInstrumentarium Imaging, Inc.
Decision Date2000-11-29
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DELTA 32 AND DELTA 32 TACT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Imaging, Inc.. It received FDA 510(k) clearance on 2000-11-29 under 510(k) number K002472. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA 32 AND DELTA 32 TACT?

DELTA 32 AND DELTA 32 TACT is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K002472.

When did DELTA 32 AND DELTA 32 TACT receive FDA 510(k) clearance?

DELTA 32 AND DELTA 32 TACT received FDA 510(k) clearance on 2000-11-29, under 510(k) number K002472.

Who is the listed applicant for DELTA 32 AND DELTA 32 TACT?

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

What is the FDA product code for DELTA 32 AND DELTA 32 TACT?

The FDA product code for DELTA 32 AND DELTA 32 TACT is IZH.

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Other records listing Instrumentarium Imaging, 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: IZH)

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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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