The following data is part of a premarket notification filed by Fairchild Medical Systems, Inc. with the FDA for Aim N' Shoot - Automatic Exposure Control.
| Device ID | K850678 |
| 510k Number | K850678 |
| Device Name: | AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL |
| Classification | System, X-ray, Mobile |
| Applicant | FAIRCHILD MEDICAL SYSTEMS, INC. 79 TOSCA DR. Stoughton, MA 02072 |
| Contact | Richard A Fairchild |
| Correspondent | Richard A Fairchild FAIRCHILD MEDICAL SYSTEMS, INC. 79 TOSCA DR. Stoughton, MA 02072 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-04-18 |