The following data is part of a premarket notification filed by American Health Care Systems, Inc. with the FDA for Ahcs Hemoperfusion System.
| Device ID | K971015 |
| 510k Number | K971015 |
| Device Name: | AHCS HEMOPERFUSION SYSTEM |
| Classification | Apparatus, Hemoperfusion, Sorbent |
| Applicant | AMERICAN HEALTH CARE SYSTEMS, INC. 3350 RIDGELAKE AVE., SUITE 255 Metairie, LA 70002 |
| Contact | Earl G Schmit |
| Correspondent | Earl G Schmit AMERICAN HEALTH CARE SYSTEMS, INC. 3350 RIDGELAKE AVE., SUITE 255 Metairie, LA 70002 |
| Product Code | FLD |
| CFR Regulation Number | 876.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-10-22 |