The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Ultra Pci.
| Device ID | K921426 |
| 510k Number | K921426 |
| Device Name: | ULTRA PCI |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED MEDICAL PRODUCTS, INC. 4709 CROSSROADS PARK DR. Liverpool, NY 13088 |
| Contact | Earl D Martin |
| Correspondent | Earl D Martin ADVANCED MEDICAL PRODUCTS, INC. 4709 CROSSROADS PARK DR. Liverpool, NY 13088 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-10-05 |