CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Connex(r) Vital Signs Monitor 6000 Series.

Pre-market Notification Details

Device IDK112687
510k NumberK112687
Device Name:CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactKevin Crossen
CorrespondentKevin Crossen
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-15
Decision Date2011-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00732094150179 K112687 000
00732094056112 K112687 000
00732094056075 K112687 000
00732094056020 K112687 000
00732094056006 K112687 000
00732094055849 K112687 000
00732094055740 K112687 000
00732094055597 K112687 000
00732094055535 K112687 000
00732094055467 K112687 000
00732094055412 K112687 000
00732094055207 K112687 000
00732094055054 K112687 000
00732094300116 K112687 000
00732094300109 K112687 000
00732094300062 K112687 000
00732094300048 K112687 000
00732094056174 K112687 000
00732094057027 K112687 000
00732094057676 K112687 000
00732094119336 K112687 000
00732094118964 K112687 000
00732094118940 K112687 000
00732094118926 K112687 000
00732094118902 K112687 000
00732094118889 K112687 000
00732094118865 K112687 000
00732094118841 K112687 000
00732094118827 K112687 000
00732094118803 K112687 000
00732094118780 K112687 000
00732094118773 K112687 000
00732094062540 K112687 000
00732094058352 K112687 000
00732094057775 K112687 000
00732094057713 K112687 000
00732094300031 K112687 000

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