• 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
111 to 120 of 167 Results
ProductCode: MNR Decision Date To: 09/26/2021
Results per Page
New Search  
Export all 167 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
clinical oxygen dose recorder (codr), model 300-cr INSPIRED TECHNOLOGIES, INC. K082853 03/23/2009
audicor cpam with sdb (single sensor) INOVISE MEDICAL, INC. K130660 10/11/2013
audicor ca300/cc100 analyzer with sdb INOVISE MEDICAL, INC. K151433 03/18/2016
audicor cpam with sdb (cardiopulmonary ambulatory monitor with sleep disordered breathing detection) INOVISE MEDICAL, INC. K120462 09/20/2012
audicor cpam with sdb (accelerometer based) INOVISE MEDICAL, INC. K131883 04/11/2014
inomax ds (delivery system) INO THERAPEUTICS LLC K090958 06/18/2009
sleepstrip disposable apnea screener INFLUENT LTD. K002135 12/06/2000
apneacheck IM SYSTEMS K022294 04/25/2003
hc1000p sleep diagnosis software system HYPNOCORE, LTD. K073269 04/18/2008
simon multichannel recording system, model 5500 HEALTHDYNE TECHNOLOGIES, INC. K983572 03/19/1999