The following data is part of a premarket notification filed by Aerotel Medical Systems (1998) Ltd. with the FDA for Bp-tel Trans-telephonic Blood Pressure Measurement System.
| Device ID | K983717 |
| 510k Number | K983717 |
| Device Name: | BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AEROTEL MEDICAL SYSTEMS (1998) LTD. 5 HATZOREF ST. Holon, IL 58856 |
| Contact | George Myers |
| Correspondent | George Myers AEROTEL MEDICAL SYSTEMS (1998) LTD. 5 HATZOREF ST. Holon, IL 58856 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-21 |
| Decision Date | 1999-09-16 |
| Summary: | summary |