The following data is part of a premarket notification filed by Commwell R&d Ltd. with the FDA for Physioglove Et System.
| Device ID | K133703 |
| 510k Number | K133703 |
| Device Name: | PHYSIOGLOVE ET SYSTEM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | COMMWELL R&D LTD. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathon Kahan |
| Correspondent | Jonathon Kahan COMMWELL R&D LTD. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-03 |
| Decision Date | 2014-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012672026 | K133703 | 000 |