The following data is part of a premarket notification filed by Smith Industries Medical Systems (sims) with the FDA for Ventilation Mechanics Monitor Model Vmm-100.
| Device ID | K936156 |
| 510k Number | K936156 |
| Device Name: | VENTILATION MECHANICS MONITOR MODEL VMM-100 |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | SMITH INDUSTRIES MEDICAL SYSTEMS (SIMS) 2552 MCGAW AVE. Irvine, CA 92714 |
| Contact | Gordon Shigezawa |
| Correspondent | Gordon Shigezawa SMITH INDUSTRIES MEDICAL SYSTEMS (SIMS) 2552 MCGAW AVE. Irvine, CA 92714 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1995-06-27 |