The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter.
| Device ID | K974389 |
| 510k Number | K974389 |
| Device Name: | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER |
| Classification | Transducer, Pressure, Intrauterine |
| Applicant | CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Contact | Wm. Dean Wallace |
| Correspondent | Wm. Dean Wallace CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Product Code | HFN |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1998-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814247020277 | K974389 | 000 |
| 20814247020172 | K974389 | 000 |
| 00814247020192 | K974389 | 000 |
| 00814247020208 | K974389 | 000 |
| 00814247020215 | K974389 | 000 |
| 00814247020222 | K974389 | 000 |
| 00814247020239 | K974389 | 000 |
| 00814247020246 | K974389 | 000 |
| 00814247020253 | K974389 | 000 |
| 00814247020260 | K974389 | 000 |
| 00814247020154 | K974389 | 000 |