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 K221030
Device Name Model 9100 PFT/DICO
Applicant
Vitalograph Ireland, Ltd.
Gort Rd. Business Park
Ennis Co Clare,  IE V95 HFT4
Applicant Contact Tony O'Hanlon
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/07/2022
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-