The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Trantec Disposable Pressure Trans.53-600/f/f30.
| Device ID | K872596 |
| 510k Number | K872596 |
| Device Name: | TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Corrine M Taflinger |
| Correspondent | Corrine M Taflinger AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-02 |
| Decision Date | 1987-09-30 |