The following data is part of a premarket notification filed by Brentwood Medical Technology Corp. with the FDA for Iqmark Digital Holter.
| Device ID | K031466 |
| 510k Number | K031466 |
| Device Name: | IQMARK DIGITAL HOLTER |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Contact | Ruomei Zhang |
| Correspondent | Ruomei Zhang BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2003-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709118067 | K031466 | 000 |