UST-5268P-5 Transducer
FDA 510(k) K950607 · Aloka Co., Ltd.
510(k) numberK950607
Submission
- Device name
- UST-5268P-5 Transducer
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- February 9, 1995
- Decision date
- September 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRK – Manometer, Blood-Pressure, Venous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1140
- Specialty
- Cardiovascular
Other 510(k)s with product code KRK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904674 | Central Venous Pressure ManometerKRK · Traditional | Medex, Inc. | 12/27/1990SE |
| K884386 | Administration/Manometer Set W/3 Way StopcockKRK · Traditional | Ethitek Pharmaceuticals Co. | 01/05/1989SE |
| K875322 | Modified Schneider-Shiley Pressure ManometerKRK · Traditional | Schneider-Shilley (Usa) | 03/28/1988SE |
| K861605 | Schneider-Shiley Pressure ManometerKRK · Traditional | Shiley, Inc. | 05/28/1986SE |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | Exco, Inc. | 04/05/1983SE |
| K813498 | MedifixKRK · Traditional | Burron Medical Products, Inc. | 01/07/1982SE |
| K813195 | Medifix Graduated ScaleKRK · Traditional | Burron Medical Products, Inc. | 12/29/1981SE |
| K790668 | Venous Pressure Monitor, MF 35 LFKRK · Traditional | Deco Medical, Inc. | 05/23/1979SE |
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Questions and answers
When was UST-5268P-5 Transducer cleared by the FDA?
UST-5268P-5 Transducer (K950607) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 218 days after the submission was received.
What is the product code of K950607?
The FDA product code is KRK – Manometer, Blood-Pressure, Venous, a Class II (moderate risk) device regulated under 21 CFR 870.1140.