Modified Cardiocap Monitor
FDA 510(k) K862455 · Datex Division Instrumentarium Corp.
510(k) numberK862455
Submission
- Device name
- Modified Cardiocap Monitor
- Applicant
- Datex Division Instrumentarium Corp.
Wilmington, MA, US - Received
- June 27, 1986
- Decision date
- September 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
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Questions and answers
When was Modified Cardiocap Monitor cleared by the FDA?
Modified Cardiocap Monitor (K862455) received a 510(k) decision of Substantially Equivalent on September 24, 1986, 89 days after the submission was received.
What is the product code of K862455?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.