The following data is part of a premarket notification filed by A.r Guide In Medical Ltd. with the FDA for Irris (infra-red-red Intubation System).
| Device ID | K171411 |
| 510k Number | K171411 |
| Device Name: | IRRIS (Infra-Red-Red Intubation System) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | A.R Guide In Medical Ltd. 13 Wadi El Haj Nazareth, IL 17111 |
| Contact | Ariel Shrem |
| Correspondent | George J. Hattub MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-15 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608614333820 | K171411 | 000 |
| 00608614324521 | K171411 | 000 |