The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Oxygen Concentrator.
| Device ID | K924100 |
| 510k Number | K924100 |
| Device Name: | OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Contact | Wayne Karcher |
| Correspondent | Wayne Karcher ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1993-03-19 |