The following data is part of a premarket notification filed by Brentwood Medical Technology Corp. with the FDA for Iqmark Ez Stress.
| Device ID | K052898 |
| 510k Number | K052898 |
| Device Name: | IQMARK EZ STRESS |
| Classification | Electrocardiograph |
| Applicant | BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Contact | Ruomei Zhang |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-14 |
| Decision Date | 2006-03-28 |
| Summary: | summary |