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 |