Sure-Lock Electrode Clip, Model CL-34, CL-A60, Cl-Hw, Cl-Tl
FDA 510(k) K080605 · Curbell Electronics, Inc.
510(k) numberK080605
Submission
- Device name
- Sure-Lock Electrode Clip, Model CL-34, CL-A60, Cl-Hw, Cl-Tl
- Applicant
- Curbell Electronics, Inc.
Orchard Park, NY, US - Received
- March 4, 2008
- Decision date
- May 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
More from Baylis Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081762 | Curbell Patient Monitoring CablesDSA · Abbreviated | 08/27/2008SE |
Questions and answers
When was Sure-Lock Electrode Clip, Model CL-34, CL-A60, Cl-Hw, Cl-Tl cleared by the FDA?
Sure-Lock Electrode Clip, Model CL-34, CL-A60, Cl-Hw, Cl-Tl (K080605) received a 510(k) decision of Substantially Equivalent on May 5, 2008, 62 days after the submission was received.
What is the product code of K080605?
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.