The following data is part of a premarket notification filed by The Ludlow Company Lp with the FDA for Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes.
| Device ID | K012218 |
| 510k Number | K012218 |
| Device Name: | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | THE LUDLOW COMPANY LP TWO LUDLOW PARK DR. Chicopee, MA 01022 |
| Contact | Kathleen M Tremblay |
| Correspondent | Kathleen M Tremblay THE LUDLOW COMPANY LP TWO LUDLOW PARK DR. Chicopee, MA 01022 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884527022384 | K012218 | 000 |
| 10884527022342 | K012218 | 000 |
| 10884527022335 | K012218 | 000 |
| 10884527022328 | K012218 | 000 |
| 20884527022318 | K012218 | 000 |
| 10884527022304 | K012218 | 000 |
| 10884527015610 | K012218 | 000 |
| 10884527015603 | K012218 | 000 |
| 10884527015597 | K012218 | 000 |
| 20884527022356 | K012218 | 000 |
| 10884527022366 | K012218 | 000 |
| 30884527022353 | K012218 | 000 |
| 30884527022315 | K012218 | 000 |
| 30884527015607 | K012218 | 000 |
| 30884521140909 | K012218 | 000 |
| 10884527022403 | K012218 | 000 |
| 10884527022397 | K012218 | 000 |
| 20884527022387 | K012218 | 000 |
| 10884527022373 | K012218 | 000 |
| 10884527015580 | K012218 | 000 |