The following data is part of a premarket notification filed by Cardiovascular Imaging Systems, Inc. with the FDA for Cvis Ultra-scan One Imaging System.
| Device ID | K891386 |
| 510k Number | K891386 |
| Device Name: | CVIS ULTRA-SCAN ONE IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Chip Jennings |
| Correspondent | Chip Jennings CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-05-16 |