The following data is part of a premarket notification filed by Houston Medical Robotics with the FDA for Euclid (tm) Tier 1-gw Access System.
| Device ID | K111426 |
| 510k Number | K111426 |
| Device Name: | EUCLID (TM) TIER 1-GW ACCESS SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HOUSTON MEDICAL ROBOTICS 42 NORTH CHANTSONG CIRCLE The Woodlands, TX 77382 |
| Contact | Darla J Elkin |
| Correspondent | Darla J Elkin HOUSTON MEDICAL ROBOTICS 42 NORTH CHANTSONG CIRCLE The Woodlands, TX 77382 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2012-03-01 |
| Summary: | summary |