The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Be #16 - Manifold.
| Device ID | K823481 |
| 510k Number | K823481 |
| Device Name: | BE #16 - MANIFOLD |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1982-12-22 |