510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101198Substantially Equivalent

Csi Managed Health System Model: Csi Model 9K

Computerized Screening, Inc., Reno NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101198 is the FDA 510(k) clearance record for CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K, a class II device, cleared for Computerized Screening, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 2 510(k) clearances for Computerized Screening, Inc., from to . As of , FDA records show no recalls naming K101198.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Computerized Screening, Inc. 9550 Gateway Dr., Reno NV
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261