The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Npb-4000.
| Device ID | K962424 |
| 510k Number | K962424 |
| Device Name: | NPB-4000 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | James R Levani |
| Correspondent | James R Levani ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-12-20 |