The following data is part of a premarket notification filed by Braemar Corp. with the FDA for Braemar Er700 Series Ambulatory Ecg Event Monitor Models Er710,er720.
| Device ID | K981394 |
| 510k Number | K981394 |
| Device Name: | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Contact | David Norberg |
| Correspondent | David Norberg BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-17 |
| Decision Date | 1998-09-28 |
| Summary: | summary |