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 ventilatory effort recorder
510(k) Number K990199
Device Name SMARTRECORDER, MODEL 2500
Applicant
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH,  PA  15221 -4401
Applicant Contact BETSY CORTELLONI
Correspondent
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH,  PA  15221 -4401
Correspondent Contact BETSY CORTELLONI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/21/1999
Decision Date 04/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-