V1 Multi-Port Connector, Model Pad V1-MPC
FDA 510(k) K062577 · Tz Medical, Inc.
510(k) numberK062577
Submission
- Device name
- V1 Multi-Port Connector, Model Pad V1-MPC
- Applicant
- Tz Medical, Inc.
Portland, OR, US - Received
- August 31, 2006
- Decision date
- December 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
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| K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandQSY · Traditional | 05/11/2004SE |
| K021421 | Padtac Electrophysiology Recording Catheters, Junction Cable Connector & CableDRF · Traditional | 04/18/2003SE |
| K001634 | Cardiosentry Event Monitor, Model 8470-01DXH · Traditional | 12/21/2000SE |
| K993205 | Booker Box, Model Pad 5010LDD · Traditional | 07/20/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | 09/15/1999SE |
Questions and answers
When was V1 Multi-Port Connector, Model Pad V1-MPC cleared by the FDA?
V1 Multi-Port Connector, Model Pad V1-MPC (K062577) received a 510(k) decision of Substantially Equivalent on December 15, 2006, 106 days after the submission was received.
What is the product code of K062577?
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.