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FDA 510(k)

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM

K-Number: K864837 · 1987-01-30

ApplicantOec-Diasonics, Inc.
Decision Date1987-01-30
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Oec-Diasonics, Inc.. It received FDA 510(k) clearance on 1987-01-30 under 510(k) number K864837. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM?

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM is a medical device that received FDA 510(k) clearance on 1987-01-30. The listed applicant is Oec-Diasonics, Inc.. The 510(k) number is K864837.

When did MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM receive FDA 510(k) clearance?

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM received FDA 510(k) clearance on 1987-01-30, under 510(k) number K864837.

Who is the listed applicant for MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM?

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

What is the FDA product code for MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM?

The FDA product code for MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM is JAA.

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Other records listing Oec-Diasonics, Inc. as applicant

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Related Devices (Code: JAA)

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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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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