WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM

Blood Pressure Cuff

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Durashock Blood Pressure System.

Pre-market Notification Details

Device IDK012455
510k NumberK012455
Device Name:WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
ClassificationBlood Pressure Cuff
Applicant WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden,  NC  28704
ContactDavid A Young
CorrespondentDavid A Young
WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden,  NC  28704
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-01
Decision Date2001-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00732094082579 K012455 000
00732094084382 K012455 000
00732094083965 K012455 000
00732094083941 K012455 000
00732094083927 K012455 000
00732094083903 K012455 000
00732094083880 K012455 000
00732094083866 K012455 000
00732094083514 K012455 000
00732094084405 K012455 000
00732094084429 K012455 000
00732094084924 K012455 000
00732094084870 K012455 000
00732094084832 K012455 000
00732094084818 K012455 000
00732094084634 K012455 000
00732094084610 K012455 000
00732094084498 K012455 000
00732094084474 K012455 000
00732094083385 K012455 000
00732094083361 K012455 000
00732094046748 K012455 000
00732094046717 K012455 000
00732094237191 K012455 000
00732094237184 K012455 000
00732094237177 K012455 000
00732094237160 K012455 000
00732094236170 K012455 000
00732094236163 K012455 000
00732094046755 K012455 000
00732094079340 K012455 000
00732094083347 K012455 000
00732094083323 K012455 000
00732094083309 K012455 000
00732094083194 K012455 000
00732094083170 K012455 000
00732094083149 K012455 000
00732094079388 K012455 000
00732094079364 K012455 000
00732094085143 K012455 000
00732094085341 K012455 000
00732094085365 K012455 000
00732094109856 K012455 000
00732094109825 K012455 000
00732094109801 K012455 000
00732094109788 K012455 000
00732094109764 K012455 000
00732094109740 K012455 000
00732094109726 K012455 000
00732094109696 K012455 000
00732094109900 K012455 000
00732094109955 K012455 000
00732094110609 K012455 000
00732094110579 K012455 000
00732094110548 K012455 000
00732094110494 K012455 000
00732094110463 K012455 000
00732094110128 K012455 000
00732094110104 K012455 000
00732094110081 K012455 000
00732094109672 K012455 000
00732094109658 K012455 000
00732094085662 K012455 000
00732094085631 K012455 000
00732094085617 K012455 000
00732094085495 K012455 000
00732094085488 K012455 000
00732094085457 K012455 000
00732094085419 K012455 000
00732094085389 K012455 000
00732094085815 K012455 000
00732094085839 K012455 000
00732094109603 K012455 000
00732094109580 K012455 000
00732094096644 K012455 000
00732094096620 K012455 000
00732094096606 K012455 000
00732094096583 K012455 000
00732094085907 K012455 000
00732094085884 K012455 000
00732094213058 K012455 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.