510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K921846Substantially Equivalent

Oceania Health Care Systems Electronic Medical Rec

Oceania Health Care Systems, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921846 is the FDA 510(k) clearance record for OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC, cleared for Oceania Health Care Systems, Inc. on under FDA product code LNX. FDA records list one 510(k) clearance for Oceania Health Care Systems, Inc. As of , FDA records show no recalls naming K921846.

Clearance record

Decision date
Received
(843 days to decision)
Product code
LNX
Review panel
Unknown
Applicant
Oceania Health Care Systems, Inc. 325 Lytton Ave., Palo Alto CA
510(k) summary
Summary
Third party review
No

Clearances, product code LNX

Trailing 12 months

FDA records hold no clearances under product code LNX in the trailing twelve months.

FDA records show no clearances under product code LNX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LNX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260