The following data is part of a premarket notification filed by Curbell Electronics Inc. with the FDA for Sure-lock Electrode Clip, Model Cl-34, Cl-a60, Cl-hw, Cl-tl.
| Device ID | K080605 |
| 510k Number | K080605 |
| Device Name: | SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | CURBELL ELECTRONICS INC. 20 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Michael J Winter |
| Correspondent | Michael J Winter CURBELL ELECTRONICS INC. 20 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-04 |
| Decision Date | 2008-05-05 |
| Summary: | summary |