The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Nuclear Laser Alignment System For Cardic Stress.
| Device ID | K860472 |
| 510k Number | K860472 |
| Device Name: | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 815 E. LOCUST Springfield, MO 65803 |
| Contact | Michael Davis |
| Correspondent | Michael Davis NUCLEAR DIAGNOSTICS, INC. 815 E. LOCUST Springfield, MO 65803 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-06 |
| Decision Date | 1986-07-03 |