The following data is part of a premarket notification filed by Flotec, Inc. with the FDA for Ambu Oxygen Regulator.
| Device ID | K901623 |
| 510k Number | K901623 |
| Device Name: | AMBU OXYGEN REGULATOR |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | FLOTEC, INC. 8132 WOODLAND DR. Indianapolis, IN 46278 |
| Contact | C Klopstad |
| Correspondent | C Klopstad FLOTEC, INC. 8132 WOODLAND DR. Indianapolis, IN 46278 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-06 |
| Decision Date | 1990-04-26 |