The following data is part of a premarket notification filed by Isansys Lifecare Ltd with the FDA for Patient Status Engine.
| Device ID | K172329 |
| 510k Number | K172329 |
| Device Name: | Patient Status Engine |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Isansys Lifecare Ltd 8C Park Square Milton Park, Abingdon Oxford, GB Ox14 4rr |
| Contact | Julian Jones |
| Correspondent | André Kindsvater Emergo Global Consulting , LLC 2500 Bee Cave Road Austin, TX 78746 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-02 |
| Decision Date | 2018-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488680311 | K172329 | 000 |
| 05060488680021 | K172329 | 000 |
| 05060488680038 | K172329 | 000 |
| 05060488680144 | K172329 | 000 |
| 05060488680151 | K172329 | 000 |
| 05060488680168 | K172329 | 000 |
| 05060488680175 | K172329 | 000 |
| 05060488680182 | K172329 | 000 |
| 05060488680205 | K172329 | 000 |
| 05060488680250 | K172329 | 000 |
| 05060488680267 | K172329 | 000 |
| 05060488680045 | K172329 | 000 |
| 05060488680052 | K172329 | 000 |
| 05060488680069 | K172329 | 000 |
| 05060488680304 | K172329 | 000 |
| 05060488680014 | K172329 | 000 |