510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904328Substantially Equivalent

Vista Polysomnography Computer System

Telediagnostic Systems, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904328 is the FDA 510(k) clearance record for VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM, a class II device, cleared for Telediagnostic Systems, Inc. on under FDA product code GWK (Conditioner, Signal, Physiological). FDA records list 14 510(k) clearances for Telediagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K904328.

Clearance record

Decision date
Received
(271 days to decision)
Product code
GWK Conditioner, Signal, Physiological
Regulation
21 CFR 882.1845
Device class
Class II
Review panel
Neurology
Applicant
Telediagnostic Systems, Inc. 2053 Sutter St., San Francisco CA
Third party review
No

Clearances, product code GWK

Trailing 12 months

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

FDA records show no clearances under product code GWK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWK, 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