The following data is part of a premarket notification filed by Abbott Medical Electronics Co. with the FDA for Abby Ii Patient Monitor Or Vital Signs M.
| Device ID | K801515 |
| 510k Number | K801515 |
| Device Name: | ABBY II PATIENT MONITOR OR VITAL SIGNS M |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | ABBOTT MEDICAL ELECTRONICS CO. Houston, TX |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-30 |
| Decision Date | 1980-07-08 |