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 Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K883825
Device Name MODIFIED SANDERS BI-PAPEASY
Applicant
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact EUGENE N SCARBERRY
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact EUGENE N SCARBERRY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received09/09/1988
Decision Date 12/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-