The following data is part of a premarket notification filed by Sensititre Ltd. with the FDA for Sensititre Aris Module.
| Device ID | K911419 |
| 510k Number | K911419 |
| Device Name: | SENSITITRE ARIS MODULE |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | SENSITITRE LTD. 811 SHARON DR. Westlake, OH 44145 |
| Contact | Laura Basista |
| Correspondent | Laura Basista SENSITITRE LTD. 811 SHARON DR. Westlake, OH 44145 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1992-07-01 |