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, predicted values, pulmonary function
510(k) Number K864087
Device Name PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
Applicant
MEDICAL ASSOCIATED SERVICES, INC.
P.O. BOX 530
HATFIELD,  PA  19440
Applicant Contact MYERS, JR.
Correspondent
MEDICAL ASSOCIATED SERVICES, INC.
P.O. BOX 530
HATFIELD,  PA  19440
Correspondent Contact MYERS, JR.
Regulation Number868.1890
Classification Product Code
BTY  
Date Received10/21/1986
Decision Date 11/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-