The following data is part of a premarket notification filed by Medical X-ray Intl., Inc. with the FDA for Infrared Exposure Hand Switch.
| Device ID | K950442 |
| 510k Number | K950442 |
| Device Name: | INFRARED EXPOSURE HAND SWITCH |
| Classification | Table, Radiologic |
| Applicant | MEDICAL X-RAY INTL., INC. 75 MANCHASTER AVE. Keyport, NJ 07735 |
| Contact | Timothy D Telymonde |
| Correspondent | Timothy D Telymonde MEDICAL X-RAY INTL., INC. 75 MANCHASTER AVE. Keyport, NJ 07735 |
| Product Code | KXJ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-03-31 |