• 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 K223629
Device Name SpiroSphere, SpiroSphereECG, CardioSphere
Applicant
eResearchTechnology GmbH
Sieboldstrasse 3
Estenfeld,  DE 97230
Applicant Contact Kristin Feld
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
DPS  
Date Received12/05/2022
Decision Date 05/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-