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FDA 510(k)

THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

K-Number: K001006 · 2000-04-27

ApplicantMds Nordion
Decision Date2000-04-27
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE is the device name listed in this FDA 510(k) record. The listed applicant is Mds Nordion. It received FDA 510(k) clearance on 2000-04-27 under 510(k) number K001006. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE?

THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE is a medical device that received FDA 510(k) clearance on 2000-04-27. The listed applicant is Mds Nordion. The 510(k) number is K001006.

When did THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE receive FDA 510(k) clearance?

THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE received FDA 510(k) clearance on 2000-04-27, under 510(k) number K001006.

Who is the listed applicant for THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE?

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

What is the FDA product code for THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE?

The FDA product code for THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE is IWB.

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 Mds Nordion 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 7 devices →

Related Devices (Code: IWB)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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