The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Elatec Holter Analyzer.
| Device ID | K895806 |
| 510k Number | K895806 |
| Device Name: | ELATEC HOLTER ANALYZER |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Paul Kohl |
| Correspondent | Paul Kohl ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-28 |
| Decision Date | 1990-04-04 |