The following data is part of a premarket notification filed by Commwell Ltd. with the FDA for Physioglove For Use With Physioglove Es1.
| Device ID | K083677 |
| 510k Number | K083677 |
| Device Name: | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 |
| Classification | Electrode, Electrocardiograph |
| Applicant | COMMWELL LTD. 555 THIRTEENTH ST., NW Washington, DC 20004 -1109 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan COMMWELL LTD. 555 THIRTEENTH ST., NW Washington, DC 20004 -1109 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-11 |
| Decision Date | 2009-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012672019 | K083677 | 000 |