The following data is part of a premarket notification filed by Commwell Ltd. with the FDA for Physioglove Es.
Device ID | K050674 |
510k Number | K050674 |
Device Name: | PHYSIOGLOVE ES |
Classification | Electrocardiograph |
Applicant | COMMWELL LTD. 555 THIRTEENTH ST., NW Washington, DC 20004 -1109 |
Contact | Jonathan S Kahn |
Correspondent | Jonathan S Kahn COMMWELL LTD. 555 THIRTEENTH ST., NW Washington, DC 20004 -1109 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-15 |
Decision Date | 2006-04-25 |
Summary: | summary |