The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Pressure Monitor Cath Models Sp5325,sp5327,sp5337.
| Device ID | K860805 |
| 510k Number | K860805 |
| Device Name: | PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-05-08 |