The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Spectra Central Pt Monitoring Sys.
| Device ID | K792081 |
| 510k Number | K792081 |
| Device Name: | SPECTRA CENTRAL PT MONITORING SYS |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-16 |
| Decision Date | 1979-11-13 |