The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Cm 3.
| Device ID | K810348 |
| 510k Number | K810348 |
| Device Name: | CM 3 |
| Classification | Valve, Non-rebreathing |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-10 |
| Decision Date | 1981-02-23 |