The following data is part of a premarket notification filed by Fluke Biomedical with the FDA for Esa615.
| Device ID | K121860 |
| 510k Number | K121860 |
| Device Name: | ESA615 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | FLUKE BIOMEDICAL 6045 COCHRAN RD. Solon, OH 44139 |
| Contact | John Nelson |
| Correspondent | John Nelson FLUKE BIOMEDICAL 6045 COCHRAN RD. Solon, OH 44139 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-26 |
| Decision Date | 2013-01-25 |
| Summary: | summary |