The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Dash 3000, 4000, 5000 Monitor And Accessories.
| Device ID | K073462 |
| 510k Number | K073462 |
| Device Name: | MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 86 PILGRIN RD. Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 86 PILGRIN RD. Needham, MA 02492 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-10 |
| Decision Date | 2008-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682123662 | K073462 | 000 |
| 00840682123655 | K073462 | 000 |