The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Spectramed Disposable Transducer (dt-xxo) & Access.
| Device ID | K873168 |
| 510k Number | K873168 |
| Device Name: | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-11 |
| Decision Date | 1988-01-12 |