The following data is part of a premarket notification filed by Ludlow Technical Products with the FDA for Surelock(tm) Snapless Monitoring Electrode.
| Device ID | K931903 |
| 510k Number | K931903 |
| Device Name: | SURELOCK(TM) SNAPLESS MONITORING ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK P.O. BOX 297 Chicopee, MA 01021 -0297 |
| Contact | Nilay Sankalia |
| Correspondent | Nilay Sankalia LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK P.O. BOX 297 Chicopee, MA 01021 -0297 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-15 |
| Decision Date | 1993-10-07 |