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 Recorder, Magnetic Tape, Medical
510(k) Number K201077
Device Name Strados Remote Electronic Stethoscope Platform (RESP)
Applicant
Strados Labs
1315 Walnut Street, Suite 1101
Philadelphia,  PA  19107
Applicant Contact Nicholas Delmonico
Correspondent
Powers Regulatory Consulting/64954
2451 Cumberland Parkway SE Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number870.2800
Classification Product Code
DSH  
Date Received04/22/2020
Decision Date 12/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-