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FDA 510(k)

SHADOWFORM

K-Number: K964972 · 1997-05-05

ApplicantI.Z.I. Medical Products Corp.
Decision Date1997-05-05
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHADOWFORM is the device name listed in this FDA 510(k) record. The listed applicant is I.Z.I. Medical Products Corp.. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K964972. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHADOWFORM?

SHADOWFORM is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is I.Z.I. Medical Products Corp.. The 510(k) number is K964972.

When did SHADOWFORM receive FDA 510(k) clearance?

SHADOWFORM received FDA 510(k) clearance on 1997-05-05, under 510(k) number K964972.

Who is the listed applicant for SHADOWFORM?

The FDA 510(k) record lists I.Z.I. Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHADOWFORM?

The FDA product code for SHADOWFORM is KPQ.

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.

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Other records listing I.Z.I. Medical Products Corp. 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.

K990242TOPOGRAPHIC IMAGING MARKERK990298TOPOGRAPHIC IMAGING MARKERK962606TOPOGRAPHIC IMAGING MARKER

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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