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 Calculator, Pulmonary Function Interpretor (Diagnostic)
510(k) Number K880550
Device Name BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS
Applicant
MEDIMICRO SYSTEMS, INC.
3107 N. JACKSON AVE.
TUCSON,  AZ  85719
Applicant Contact RONALD C SLATIN
Correspondent
MEDIMICRO SYSTEMS, INC.
3107 N. JACKSON AVE.
TUCSON,  AZ  85719
Correspondent Contact RONALD C SLATIN
Regulation Number868.1900
Classification Product Code
BZM  
Date Received02/09/1988
Decision Date 07/25/1988
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
-
-