The following data is part of a premarket notification filed by Healthdyne Cardiovascular, Inc. with the FDA for Isoflo Intrauterine Pressure Monitoring & Amnio..
| Device ID | K901084 |
| 510k Number | K901084 |
| Device Name: | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine, CA 92618 -1658 |
| Contact | Bill Welch |
| Correspondent | Bill Welch HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine, CA 92618 -1658 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-07 |
| Decision Date | 1990-06-01 |