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FDA 510(k)

ORION PLUS/MODIFICATION

K-Number: K904840 · 1990-11-20

ApplicantMayer Laboratories
Decision Date1990-11-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORION PLUS/MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K904840. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION PLUS/MODIFICATION?

ORION PLUS/MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Mayer Laboratories. The 510(k) number is K904840.

When did ORION PLUS/MODIFICATION receive FDA 510(k) clearance?

ORION PLUS/MODIFICATION received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904840.

Who is the listed applicant for ORION PLUS/MODIFICATION?

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

What is the FDA product code for ORION PLUS/MODIFICATION?

The FDA product code for ORION PLUS/MODIFICATION is HIS.

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Related Devices (Code: HIS)

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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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