The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Model 100 Spectraview.
| Device ID | K800655 |
| 510k Number | K800655 |
| Device Name: | MODEL 100 SPECTRAVIEW |
| Classification | Phonocardiograph |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-25 |
| Decision Date | 1980-04-16 |