The following data is part of a premarket notification filed by Medi-trace Products Division with the FDA for Medi-trace Disposable Pressure Transducer.
| Device ID | K850898 |
| 510k Number | K850898 |
| Device Name: | MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MEDI-TRACE PRODUCTS DIVISION 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Contact | Albert J Amelotte |
| Correspondent | Albert J Amelotte MEDI-TRACE PRODUCTS DIVISION 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-04 |
| Decision Date | 1985-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489064711 | K850898 | 000 |
| 10193489064704 | K850898 | 000 |
| 10193489064698 | K850898 | 000 |
| 10193489064681 | K850898 | 000 |
| 10193489059120 | K850898 | 000 |
| 10193489058895 | K850898 | 000 |