The following data is part of a premarket notification filed by Aerotel Medical Systems (1998) Ltd. with the FDA for Tele-cliniq Data Transmission System Blood Pressure Measurement System.
| Device ID | K021447 |
| 510k Number | K021447 |
| Device Name: | TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AEROTEL MEDICAL SYSTEMS (1998) LTD. 377ROUTE 17 S Hasbrouck Height, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers AEROTEL MEDICAL SYSTEMS (1998) LTD. 377ROUTE 17 S Hasbrouck Height, NJ 07604 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-05-22 |
| Summary: | summary |