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FDA 510(k)

CS2000 & CS2000 TOMO

K-Number: K973834 · 1998-04-30

ApplicantPausch Corp.
Decision Date1998-04-30
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS2000 & CS2000 TOMO is the device name listed in this FDA 510(k) record. The listed applicant is Pausch Corp.. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K973834. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS2000 & CS2000 TOMO?

CS2000 & CS2000 TOMO is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Pausch Corp.. The 510(k) number is K973834.

When did CS2000 & CS2000 TOMO receive FDA 510(k) clearance?

CS2000 & CS2000 TOMO received FDA 510(k) clearance on 1998-04-30, under 510(k) number K973834.

Who is the listed applicant for CS2000 & CS2000 TOMO?

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

What is the FDA product code for CS2000 & CS2000 TOMO?

The FDA product code for CS2000 & CS2000 TOMO is IZF.

Other records listing Pausch 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.

K973864COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMOK903395UROMAT 2000K870856COSMOSK790740BS 66, UNIVERSAL BUCKY STANDK790741COMPACT SYSTEMK790742KS-78 VERTICAL WALL CASSETTE HOLDER

View all 8 devices →

Related Devices (Code: IZF)

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.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH

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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