The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model P23xl Physiological Pressure Transducer.
| Device ID | K843969 |
| 510k Number | K843969 |
| Device Name: | MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Archer S Gordon |
| Correspondent | Archer S Gordon GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1985-01-23 |