FDA 510(k)

DELTA 32; DELTA 32 TACT

K-Number: K022275 · 2002-09-12

ApplicantInstrumentarium Corp. Imaging Division

Decision Date2002-09-12

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DELTA 32; DELTA 32 TACT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp. Imaging Division. It received FDA 510(k) clearance on 2002-09-12 under 510(k) number K022275. 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; DELTA 32 TACT?

DELTA 32; DELTA 32 TACT is a medical device that received FDA 510(k) clearance on 2002-09-12. The listed applicant is Instrumentarium Corp. Imaging Division. The 510(k) number is K022275.

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

DELTA 32; DELTA 32 TACT received FDA 510(k) clearance on 2002-09-12, under 510(k) number K022275.

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

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

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

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

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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.