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 |