The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Pm-1000f+patient Monitor.
| Device ID | K082887 |
| 510k Number | K082887 |
| Device Name: | PM-1000F+PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 W 20 ST Hialeah, FL 33010 |
| Contact | Jorge Millian |
| Correspondent | Jorge Millian ADVANCED INSTRUMENTATIONS, INC. 601 W 20 ST Hialeah, FL 33010 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-01-16 |
| Summary: | summary |