The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Patient Monitor Models Pm-2000a, Pm-2000a+, Pm-2000a Pro.
| Device ID | K123048 |
| 510k Number | K123048 |
| Device Name: | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20TH STREET Hialeah, FL 33010 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510PM2000APRO1 | K123048 | 000 |
| B510PM2000A1 | K123048 | 000 |