The following data is part of a premarket notification filed by Amg Medical Equipments, Inc. with the FDA for Resuscitator's Guard Suction Control System.
| Device ID | K884917 |
| 510k Number | K884917 |
| Device Name: | RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | AMG MEDICAL EQUIPMENTS, INC. 743 MICHIGAN LN. Elk Grove, IL 60007 |
| Contact | Gajo, M.d. |
| Correspondent | Gajo, M.d. AMG MEDICAL EQUIPMENTS, INC. 743 MICHIGAN LN. Elk Grove, IL 60007 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1989-03-09 |