The following data is part of a premarket notification filed by Hanin Medical Services Co. Ltd with the FDA for Saad Patient Monitor (spm).
| Device ID | K133222 |
| 510k Number | K133222 |
| Device Name: | SAAD PATIENT MONITOR (SPM) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | HANIN MEDICAL SERVICES CO. LTD 57 LAZY BROOK ROAD Monroe, CT 06468 |
| Contact | Raymond J Kelly |
| Correspondent | Raymond J Kelly HANIN MEDICAL SERVICES CO. LTD 57 LAZY BROOK ROAD Monroe, CT 06468 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-18 |
| Decision Date | 2014-08-06 |