The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Syringe 500bc Be #7000.
| Device ID | K830898 |
| 510k Number | K830898 |
| Device Name: | SYRINGE 500BC BE #7000 |
| Classification | Calibrator, Volume, Gas |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXW |
| CFR Regulation Number | 868.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-05-16 |