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FDA 510(k)

APOLLO MOBILE C ARM SYSTEM

K-Number: K010393 · 2001-03-12

ApplicantCares Built, Inc.
Decision Date2001-03-12
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APOLLO MOBILE C ARM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cares Built, Inc.. It received FDA 510(k) clearance on 2001-03-12 under 510(k) number K010393. 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 APOLLO MOBILE C ARM SYSTEM?

APOLLO MOBILE C ARM SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-12. The listed applicant is Cares Built, Inc.. The 510(k) number is K010393.

When did APOLLO MOBILE C ARM SYSTEM receive FDA 510(k) clearance?

APOLLO MOBILE C ARM SYSTEM received FDA 510(k) clearance on 2001-03-12, under 510(k) number K010393.

Who is the listed applicant for APOLLO MOBILE C ARM SYSTEM?

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

What is the FDA product code for APOLLO MOBILE C ARM SYSTEM?

The FDA product code for APOLLO MOBILE C ARM SYSTEM 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 Cares Built, 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.

K003238SOLID STATE X-RAY IMAGING DEVICESK010391ATLAS MULTI-PURPOSE DSA SYSTEMK010392ATHENA REMOTE CONTROLLED RF SYSTEM

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

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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