Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K040490
FOIA Releasable 510(k) K040490
Device Name WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/26/2004
Decision Date 08/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-