ACCU-LEAD
Electrode, Electrocardiograph
KENTEC MEDICAL, INC.
The following data is part of a premarket notification filed by Kentec Medical, Inc. with the FDA for Accu-lead.
Pre-market Notification Details
| Device ID | K050443 |
| 510k Number | K050443 |
| Device Name: | ACCU-LEAD |
| Classification | Electrode, Electrocardiograph |
| Applicant | KENTEC MEDICAL, INC. 20492 CRESCENT BAY DR SUITE 106 Lake Forest, CA 92630 |
| Contact | David Sheraton |
| Correspondent | David Sheraton KENTEC MEDICAL, INC. 20492 CRESCENT BAY DR SUITE 106 Lake Forest, CA 92630 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-09-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817522010363 | K050443 | 000 |
| 20817522010356 | K050443 | 000 |
Trademark Results [ACCU-LEAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCU-LEAD 75580512 not registered Dead/Abandoned |
Unilead International, Inc. 1998-11-02 |
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