The following data is part of a premarket notification filed by Healthdyne Technologies, Inc. with the FDA for Alice 4r System.
| Device ID | K971867 |
| 510k Number | K971867 |
| Device Name: | ALICE 4R SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | HEALTHDYNE TECHNOLOGIES, INC. 1850 PARKWAY PLACE Marietta, GA 30067 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart HEALTHDYNE TECHNOLOGIES, INC. 1850 PARKWAY PLACE Marietta, GA 30067 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-20 |
| Decision Date | 1997-08-13 |