The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Bc 1400 Hand Positioner.
| Device ID | K872316 |
| 510k Number | K872316 |
| Device Name: | BC 1400 HAND POSITIONER |
| Classification | System, X-ray, Stationary |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | T Marrangoni |
| Correspondent | T Marrangoni INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-17 |
| Decision Date | 1987-08-12 |