The following data is part of a premarket notification filed by Meridian Medical Technologies Ltd. with the FDA for Telepress Iii Blood Pressure Monitor, Model Tpiii.
Device ID | K011058 |
510k Number | K011058 |
Device Name: | TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | MERIDIAN MEDICAL TECHNOLOGIES LTD. 207 AIRPORT RD., WEST Belfast, IE Bt3 9ed |
Contact | Rhona Love |
Correspondent | Rhona Love MERIDIAN MEDICAL TECHNOLOGIES LTD. 207 AIRPORT RD., WEST Belfast, IE Bt3 9ed |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-06 |
Decision Date | 2001-10-23 |