The following data is part of a premarket notification filed by Biosensors International-usa with the FDA for Accutrans Disposable Pressure Monitoring System.
| Device ID | K070710 |
| 510k Number | K070710 |
| Device Name: | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | BIOSENSORS INTERNATIONAL-USA 20280 ACACIA ST., SUITE 300 Newport Beach, CA 92660 |
| Contact | Sara Toyloy |
| Correspondent | Sara Toyloy BIOSENSORS INTERNATIONAL-USA 20280 ACACIA ST., SUITE 300 Newport Beach, CA 92660 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-14 |
| Decision Date | 2007-04-19 |
| Summary: | summary |