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FDA 510(k)

DIGISCOPE RX-2 (9 OPTION)

K-Number: K965013 · 1997-01-17

ApplicantMedirex, Inc.
Decision Date1997-01-17
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGISCOPE RX-2 (9 OPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Medirex, Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K965013. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGISCOPE RX-2 (9 OPTION)?

DIGISCOPE RX-2 (9 OPTION) is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Medirex, Inc.. The 510(k) number is K965013.

When did DIGISCOPE RX-2 (9 OPTION) receive FDA 510(k) clearance?

DIGISCOPE RX-2 (9 OPTION) received FDA 510(k) clearance on 1997-01-17, under 510(k) number K965013.

Who is the listed applicant for DIGISCOPE RX-2 (9 OPTION)?

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

What is the FDA product code for DIGISCOPE RX-2 (9 OPTION)?

The FDA product code for DIGISCOPE RX-2 (9 OPTION) is OXO.

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 Medirex, 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.

K964327IPU RX-2K960198DIGISCOPE RX-2

Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

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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