Modified Continuous Cardiac Output Monitor System
FDA 510(k) K882593 · Cardio Metrics, Inc.
510(k) numberK882593
Submission
- Device name
- Modified Continuous Cardiac Output Monitor System
- Applicant
- Cardio Metrics, Inc.
Mountain View, CA, US - Received
- June 24, 1988
- Decision date
- August 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K955551 | CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404DQX · Traditional | 02/28/1996SE |
| K954913 | Cardiometrics Accutrac Intravascular Guide Wire (Modification)DQX · Traditional | 11/07/1995SE |
| K952562 | Cardiometrics Accutrac Intravascular Guide WireDQX · Traditional | 08/29/1995SE |
| K943022 | Cardiometrics Flowire Doppler Guide WireDQX · Traditional | 09/19/1994SE |
| K940984 | Cardiometrics Dualflow Switch BoxDQX · Traditional | 08/18/1994SE |
| K933320 | Cardiometrics Flomap and Flomod Ultrasound InstrumentIYO · Traditional | 08/17/1994SE |
Questions and answers
When was Modified Continuous Cardiac Output Monitor System cleared by the FDA?
Modified Continuous Cardiac Output Monitor System (K882593) received a 510(k) decision of Substantially Equivalent on August 29, 1988, 66 days after the submission was received.
What is the product code of K882593?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.