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 Monitor, Apnea, Facility Use
510(k) Number K011597
Device Name SMARTMONITOR 2, MODEL 4000
Applicant
Respironics Georgia, Inc.
175 Chastain Meadows Court
Kennesaw,  GA  30144
Applicant Contact BETSY CORTELLONI
Correspondent
Respironics Georgia, Inc.
175 Chastain Meadows Court
Kennesaw,  GA  30144
Correspondent Contact BETSY CORTELLONI
Regulation Number868.2377
Classification Product Code
FLS  
Date Received05/24/2001
Decision Date 01/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-