The following data is part of a premarket notification filed by Aerotel Medical Systems, Ltd. with the FDA for Mpm System.
| Device ID | K041854 |
| 510k Number | K041854 |
| Device Name: | MPM SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AEROTEL MEDICAL SYSTEMS, LTD. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers AEROTEL MEDICAL SYSTEMS, LTD. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2004-10-06 |
| Summary: | summary |