The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Clinical Data Apnea Detector.
| Device ID | K821721 |
| 510k Number | K821721 |
| Device Name: | CLINICAL DATA APNEA DETECTOR |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | CLINICAL DATA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-10 |
| Decision Date | 1982-07-13 |