The following data is part of a premarket notification filed by Healthdyne Cardiovascular, Inc. with the FDA for Isoflo And Isotec Intrauterine Pressure Monitoring.
| Device ID | K895763 |
| 510k Number | K895763 |
| Device Name: | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | HEALTHDYNE CARDIOVASCULAR, INC. 1579 SUNLAND LN. Costa Mesa, CA 92626 |
| Contact | Bill Welch |
| Correspondent | Bill Welch HEALTHDYNE CARDIOVASCULAR, INC. 1579 SUNLAND LN. Costa Mesa, CA 92626 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-12-22 |