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 Meter, Peak Flow, Spirometry
510(k) Number K936110
Device Name ASPIRE
Applicant
Dura Pharmaceuticals, Inc.
5880 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact KATHLEEN HEFFERNAN
Correspondent
Dura Pharmaceuticals, Inc.
5880 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact KATHLEEN HEFFERNAN
Regulation Number868.1860
Classification Product Code
BZH  
Date Received12/23/1993
Decision Date 03/23/1995
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
-
-