Paceview
FDA 510(k) K915627 · Micromedical Industries, Ltd.
510(k) numberK915627
Submission
- Device name
- Paceview
- Applicant
- Micromedical Industries, Ltd.
Northbrook, IL, US - Received
- December 9, 1991
- Decision date
- March 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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| K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesKRB · Special | Pulsion Medical Systems AG | 09/19/2007SE |
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| K936182 | Critikit Plus in Line Room/Ice Temperature Injectate KitKRB · Traditional | Ohmeda Medical | 03/25/1994SE |
| K912172 | Safewedge(Tm) Relief Valve DeviceKRB · Traditional | Sunscope Intl., Inc. | 09/27/1991SE |
| K902627 | Interflo Medical Model Oxi/Co Fila. Thermo. Cath.KRB · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | Intec Medical, Inc. | 10/19/1990SE |
| K900317 | Pacemate Flow Directed Thermal Dilution CatheterKRB · Traditional | Elecath | 06/22/1990SE |
More from Elecath
| 510(k) | Device | Decision |
|---|---|---|
| K013311 | Modification to: Pocketview ECG SoftwareMHX · Special | 01/03/2002SE |
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| K990266 | Micromedical 12 Lead Simultaneous CableLOS · Special | 02/02/1999SE |
| K922528 | CMS SystemDQK · Traditional | 05/12/1995SE |
| K915624 | Modified BiologDRT · Traditional | 03/27/1992SE |
Questions and answers
When was Paceview cleared by the FDA?
Paceview (K915627) received a 510(k) decision of Substantially Equivalent on March 27, 1992, 109 days after the submission was received.
What is the product code of K915627?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.