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 Spirometer, Diagnostic
510(k) Number K921513
Device Name SPIROLITE MODEL MSC-201 SPIROMETER
Applicant
MEDICAL SYSTEMS CORP.
ONE PLAZA RD.
GREENVALE,  NY  11548 -9801
Applicant Contact MARDIN VARELA
Correspondent
MEDICAL SYSTEMS CORP.
ONE PLAZA RD.
GREENVALE,  NY  11548 -9801
Correspondent Contact MARDIN VARELA
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/31/1992
Decision Date 01/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-