Manometer Set C.V.P. #S 298/299
FDA 510(k) K830910 · Exco, Inc.
510(k) numberK830910
Submission
- Device name
- Manometer Set C.V.P. #S 298/299
- Applicant
- Exco, Inc.
Mchenry, IL, US - Received
- March 21, 1983
- Decision date
- April 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K950607 | UST-5268P-5 TransducerKRK · Traditional | Aloka Co., Ltd. | 09/15/1995SE |
| 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 |
| 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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| 510(k) | Device | Decision |
|---|---|---|
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| K844174 | Flexible Stainless Steel Stylet for Enternal FeediKNT · Traditional | 12/07/1984SE |
| K832628 | Vygon Thoracic Drainage-Various #'SKDD · Traditional | 01/30/1984SE |
| K831802 | Life Vac #2191 & 2192LJS · Traditional | 01/11/1984SE |
| K833079 | Centracath #130,135 & 137-HEMOCATH #FOZ · Traditional | 12/29/1983SE |
| K822879 | Enteral Nutrition 1KNT · Traditional | 11/16/1982SE |
| K822836 | Microflex-VenofluxFPA · Traditional | 10/15/1982SE |
| K822691 | Vygon Epidural Anaesthesia TrayCAZ · Traditional | 10/15/1982SE |
| K822724 | Suction TubesBSY · Traditional | 10/13/1982SE |
Questions and answers
When was Manometer Set C.V.P. #S 298/299 cleared by the FDA?
Manometer Set C.V.P. #S 298/299 (K830910) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 15 days after the submission was received.
What is the product code of K830910?
The FDA product code is KRK – Manometer, Blood-Pressure, Venous, a Class II (moderate risk) device regulated under 21 CFR 870.1140.