The following data is part of a premarket notification filed by Amg, Llc with the FDA for Ambu Oxygen Regulator.
| Device ID | K921125 |
| 510k Number | K921125 |
| Device Name: | AMBU OXYGEN REGULATOR |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | AMG, LLC 8904 BASH STREET, SUITE A Indianapolis, IN 46256 |
| Contact | Richard C Klopstad |
| Correspondent | Richard C Klopstad AMG, LLC 8904 BASH STREET, SUITE A Indianapolis, IN 46256 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1992-09-17 |