The following data is part of a premarket notification filed by Vision Medical Instruments, Inc. with the FDA for Vmi 1000 Surgical Paceometer.
| Device ID | K951145 |
| 510k Number | K951145 |
| Device Name: | VMI 1000 SURGICAL PACEOMETER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | VISION MEDICAL INSTRUMENTS, INC. 8147 CHAGRIN MILLS RD. Chagrin Falls, OH 44022 |
| Contact | King G Heiple Jr. |
| Correspondent | King G Heiple Jr. VISION MEDICAL INSTRUMENTS, INC. 8147 CHAGRIN MILLS RD. Chagrin Falls, OH 44022 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-13 |
| Decision Date | 1995-06-19 |