The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Be#6006 Var. Resis. Inspir. Muscle.
| Device ID | K821492 |
| 510k Number | K821492 |
| Device Name: | BE#6006 VAR. RESIS. INSPIR. MUSCLE |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-18 |
| Decision Date | 1982-09-24 |