The following data is part of a premarket notification filed by Recom Managed Systems, Inc. with the FDA for Recom Battery-operated Ambulatory Digital Wireless Ecg Monitor, Model 100.
| Device ID | K032882 |
| 510k Number | K032882 |
| Device Name: | RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | RECOM MANAGED SYSTEMS, INC. 4705 LAUREL CANYON BLVD. SUITE 203 Valley Village, CA 91607 |
| Contact | Willam R Matthews |
| Correspondent | Willam R Matthews RECOM MANAGED SYSTEMS, INC. 4705 LAUREL CANYON BLVD. SUITE 203 Valley Village, CA 91607 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2004-01-28 |
| Summary: | summary |