The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Meridian Medical Systems Hyper Inflation Bay Syst.
| Device ID | K925591 |
| 510k Number | K925591 |
| Device Name: | MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 8102 WOODLAND DR/. Indianapolis, IN 46278 |
| Contact | Robert Richmond |
| Correspondent | Robert Richmond MERIT MEDICAL SYSTEMS, INC. 8102 WOODLAND DR/. Indianapolis, IN 46278 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1993-09-16 |