The following data is part of a premarket notification filed by Adsis Ltd. with the FDA for Remote Presence And Care System (rpcs 5000).
| Device ID | K010791 |
| 510k Number | K010791 |
| Device Name: | REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | ADSIS LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ADSIS LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-15 |
| Decision Date | 2001-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012672057 | K010791 | 000 |