Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL

K-Number: K896596 · 1991-05-30

Decision Date1991-05-30
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL 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 1991-05-30 under 510(k) number K896596. 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 ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL?

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K896596.

When did ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL receive FDA 510(k) clearance?

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL received FDA 510(k) clearance on 1991-05-30, under 510(k) number K896596.

Who is the listed applicant for ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL?

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 ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL?

The FDA product code for ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL is IZH.

Related Clinical Trials

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.

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.

View all 24 devices →

Related Devices (Code: IZH)

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.

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.

↑