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FDA 510(k)

OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC

K-Number: K921846 · 1994-08-08

ApplicantOceania Health Care Systems, Inc.
Decision Date1994-08-08
Product CodeLNX
DecisionSubstantially Equivalent

Device Summary

OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC is the device name listed in this FDA 510(k) record. The listed applicant is Oceania Health Care Systems, Inc.. It received FDA 510(k) clearance on 1994-08-08 under 510(k) number K921846. The device is classified under product code LNX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC?

OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC is a medical device that received FDA 510(k) clearance on 1994-08-08. The listed applicant is Oceania Health Care Systems, Inc.. The 510(k) number is K921846.

When did OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC receive FDA 510(k) clearance?

OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC received FDA 510(k) clearance on 1994-08-08, under 510(k) number K921846.

Who is the listed applicant for OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC?

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

What is the FDA product code for OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC?

The FDA product code for OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC is LNX.

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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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