The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Mac-lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic And Electrophys.
| Device ID | K130626 |
| 510k Number | K130626 |
| Device Name: | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Philip Malca |
| Correspondent | Philip Malca GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146029 | K130626 | 000 |
| 00840682119634 | K130626 | 000 |
| 00840682119641 | K130626 | 000 |
| 00840682119665 | K130626 | 000 |
| 00840682119689 | K130626 | 000 |
| 00840682123532 | K130626 | 000 |
| 00840682123549 | K130626 | 000 |
| 00840682123556 | K130626 | 000 |
| 00840682123563 | K130626 | 000 |
| 00840682123570 | K130626 | 000 |
| 00840682123587 | K130626 | 000 |
| 00840682123594 | K130626 | 000 |
| 00840682145756 | K130626 | 000 |
| 00840682145763 | K130626 | 000 |
| 00840682145985 | K130626 | 000 |
| 00840682146012 | K130626 | 000 |
| 00840682119603 | K130626 | 000 |