WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES

System, Measurement, Blood-pressure, Non-invasive

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Spot Vital Signs Lxi Model 45000 Series.

Pre-market Notification Details

• Device ID: K101680
• 510k Number: K101680
• Device Name: WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Contact: Huy Doan
• Correspondent: Huy Doan; WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Product Code: DXN
• Subsequent Product Code: DQA
• Subsequent Product Code: FLL
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-06-15
• Decision Date: 2010-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00732094244649	K101680	000
00732094002942	K101680	000
00732094002959	K101680	000
00732094002966	K101680	000
00732094002980	K101680	000
00732094002997	K101680	000
00732094003000	K101680	000
00732094003185	K101680	000
00732094003192	K101680	000
00732094003208	K101680	000
00732094003314	K101680	000
00732094003321	K101680	000
00732094003352	K101680	000
00732094003369	K101680	000
00732094003512	K101680	000
00732094002867	K101680	000
00732094105254	K101680	000
00732094236873	K101680	000
00732094008920	K101680	000
00732094008937	K101680	000
00732094009125	K101680	000
00732094009309	K101680	000
00732094009453	K101680	000
00732094009477	K101680	000
00732094009132	K101680	000
00732094009118	K101680	000
00817655022956	K101680	000
00732094215694	K101680	000
00732094215700	K101680	000
00732094215731	K101680	000
00732094215748	K101680	000
00732094003529	K101680	000
00732094003536	K101680	000
00732094006599	K101680	000
00732094006605	K101680	000
00732094006629	K101680	000
00732094008760	K101680	000
00732094008814	K101680	000
00732094008876	K101680	000
00732094008951	K101680	000
00732094009019	K101680	000
00732094009071	K101680	000
00732094009255	K101680	000
00732094009354	K101680	000
00732094009408	K101680	000
00732094021530	K101680	000
00732094128420	K101680	000
00732094006469	K101680	000
00732094006445	K101680	000
00732094003666	K101680	000
00732094003673	K101680	000
00732094003789	K101680	000
00732094003796	K101680	000
00732094003802	K101680	000
00732094005622	K101680	000
00732094005684	K101680	000
00732094005714	K101680	000
00732094005844	K101680	000
00732094005868	K101680	000
00732094005981	K101680	000
00732094006001	K101680	000
00732094006070	K101680	000
00732094006094	K101680	000
00732094215717	K101680	000