510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912816Substantially Equivalent

Press 1 Press 2 9220 Updating of the Module

S & W Medico Teknik, Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912816 is the FDA 510(k) clearance record for PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE, a class II device, cleared for S & W Medico Teknik on under FDA product code DSK (Computer, Blood-Pressure). FDA records list 49 510(k) clearances for S & W Medico Teknik, from to . As of , FDA records show no recalls naming K912816.

Clearance record

Decision date
Received
(297 days to decision)
Product code
DSK Computer, Blood-Pressure
Regulation
21 CFR 870.1110
Device class
Class II
Review panel
Cardiovascular
Applicant
S & W Medico Teknik Herstedvang 8, Denmark, DK
510(k) summary
Statement
Third party review
No

Clearances, product code DSK

Trailing 12 months

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

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