510(k) K974389
- Device
- KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
- Applicant
- CLINICAL INNOVATIONS, INC.
- 510(k) number
- K974389
- Product code
- HFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-19
- Date received
- 1997-11-21
- Regulation
- 884.2700
- Classification name
- Transducer, Pressure, Intrauterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WM. DEAN WALLACE
- Address
- 6477 S. Cottonwood St. Murray UT US 84107 84107
FDA Registration Numbers#
- 1722684
- 1066270
- 1218950
- 3012528160
- 3003971136
- 3000126629
- 1720929
- 1718873
- 9610816
- 9681377
- 3009077524
- 3013783488
- 2032098
- 3014541700
- 3016701404
Source Documents#
Other 510(k) Records For Product Code HFN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | 2025-05-22 |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Clinical Innovations, Inc. | 1997-11-24 |
| K961424 | INTRAN 500 | Utah Medical Products, Inc. | 1996-07-10 |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1996-04-17 |
| K955443 | INTRAN PLUS | Utah Medical Products, Inc. | 1996-02-20 |
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | Telos Medical Corp. | 1992-10-27 |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | Telos Medical Corp. | 1989-10-12 |
| K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | Laurel Medical Corp. | 1989-06-12 |
Legacy Summary#
summary
FDA Review#
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