The following data is part of a premarket notification filed by Healthdyne Technologies, Inc. with the FDA for Protege Liquid Oxygen System.
| Device ID | K971545 |
| 510k Number | K971545 |
| Device Name: | PROTEGE LIQUID OXYGEN SYSTEM |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | HEALTHDYNE TECHNOLOGIES, INC. 933 WESTERN DR. Indianapolis, IN 46241 |
| Contact | Jay Hayes |
| Correspondent | Jay Hayes HEALTHDYNE TECHNOLOGIES, INC. 933 WESTERN DR. Indianapolis, IN 46241 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-07-25 |