The following data is part of a premarket notification filed by Ge Medical Syst. Information Technologies with the FDA for Mac 800 Resting Ecg Analysis System.
| Device ID | K090212 |
| 510k Number | K090212 |
| Device Name: | MAC 800 RESTING ECG ANALYSIS SYSTEM |
| Classification | Electrocardiograph |
| Applicant | GE MEDICAL SYST. INFORMATION TECHNOLOGIES 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Larry Lepley |
| Correspondent | Larry Lepley GE MEDICAL SYST. INFORMATION TECHNOLOGIES 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-28 |
| Decision Date | 2009-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682106481 | K090212 | 000 |