Medifix
FDA 510(k) K813498 · Burron Medical Products, Inc.
510(k) numberK813498
Submission
- Device name
- Medifix
- Applicant
- Burron Medical Products, Inc.
Walker, MI, US - Received
- December 14, 1981
- Decision date
- January 7, 1982
- 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 |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | Exco, Inc. | 04/05/1983SE |
| 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 |
More from Deco Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870403 | Cavafix(R) Central Venous Catheter Kit W/SutureFOZ · Traditional | 05/01/1987SE |
| K862412 | IntestoplantLLD · Traditional | 11/13/1986SE |
| K861479 | Cavafix, Central Venous Catheter KitFOZ · Traditional | 07/01/1986SESD |
| K860126 | Stimuplex, Nerve StimulatorBXN · Traditional | 02/28/1986SE |
| K851293 | ImplantofixLJT · Traditional | 01/09/1986SE |
| K841428 | Jejunostomy Set for Tube FeedingKNT · Traditional | 07/09/1984SE |
| K834383 | Dual-Lumen Long Term Central Venous CatLJS · Traditional | 05/01/1984SE |
| K834299 | Long Term Central Venous Access CathLJS · Traditional | 05/01/1984SE |
| K834473 | Multi-Lumen Central Venous Cath. KitLJS · Traditional | 04/30/1984SE |
| K840179 | Continuous Epidural Anesthes. TrayCAZ · Traditional | 02/24/1984SE |
Questions and answers
When was Medifix cleared by the FDA?
Medifix (K813498) received a 510(k) decision of Substantially Equivalent on January 7, 1982, 24 days after the submission was received.
What is the product code of K813498?
The FDA product code is KRK – Manometer, Blood-Pressure, Venous, a Class II (moderate risk) device regulated under 21 CFR 870.1140.