The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Bracket Be 122-1.
| Device ID | K770633 |
| 510k Number | K770633 |
| Device Name: | BRACKET BE 122-1 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-04 |
| Decision Date | 1977-05-23 |