The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Bc 1800 Finger Positioner.
Device ID | K872317 |
510k Number | K872317 |
Device Name: | BC 1800 FINGER 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 |