The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Lifegard Ii Family Multi-function Patient Monitor, Models An4320, An4320p, An4321p, An4322p & An3423p.
| Device ID | K050919 |
| 510k Number | K050919 |
| Device Name: | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. CENTENNIAL INDUSTRIAL PARK Peabody, MA 01960 |
| Contact | Donald Sherratt |
| Correspondent | Donald Sherratt ANALOGIC CORP. 8 CENTENNIAL DR. CENTENNIAL INDUSTRIAL PARK Peabody, MA 01960 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-12 |
| Decision Date | 2005-06-14 |
| Summary: | summary |