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 Data
510(k) Number K852909
Device Name MVP - 6000
Applicant
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903
Applicant Contact JOAN A GOETZ
Correspondent
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903
Correspondent Contact JOAN A GOETZ
Regulation Number868.1880
Classification Product Code
BZC  
Date Received07/09/1985
Decision Date 11/14/1985
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
-
-