The following data is part of a premarket notification filed by Lorad Medical Systems, Inc. with the FDA for S-70 Portable Dental X-ray System.
| Device ID | K894935 |
| 510k Number | K894935 |
| Device Name: | S-70 PORTABLE DENTAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | LORAD MEDICAL SYSTEMS, INC. EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Contact | Edward Mcdermott |
| Correspondent | Edward Mcdermott LORAD MEDICAL SYSTEMS, INC. EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1990-04-25 |