510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K062388Substantially Equivalent

Anesthesia Information and Digital-Drug Management System

Docusys, Mobile AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062388 is the FDA 510(k) clearance record for ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM, a class II device, cleared for Docusys on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list one 510(k) clearance for Docusys. As of , FDA records show no recalls naming K062388.

Clearance record

Decision date
Received
(191 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Docusys 820 S. University Blvd., Mobile AL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSZ

Trailing 12 months
2 clearances under product code BSZ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260