The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Mars Holter Analysis Workstation.
| Device ID | K093141 |
| 510k Number | K093141 |
| Device Name: | MARS HOLTER ANALYSIS WORKSTATION |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. Wauwatosa, WI 53226 |
| Contact | Joe Lucas |
| Correspondent | Joe Lucas GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. Wauwatosa, WI 53226 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2009-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682100069 | K093141 | 000 |