Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
FDA 510(k) K163316 · Carefusion 303, Inc.
510(k) numberK163316
Submission
- Device name
- Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
- Applicant
- Carefusion 303, Inc.
Vernon Hills, IL, US - Received
- November 23, 2016
- Decision date
- June 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
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Questions and answers
When was Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System cleared by the FDA?
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (K163316) received a 510(k) decision of Substantially Equivalent on June 22, 2017, 211 days after the submission was received.
What is the product code of K163316?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.