The following data is part of a premarket notification filed by Contour Electrodes, Inc. with the FDA for L30-lb- Infant Limb Band.
| Device ID | K893245 |
| 510k Number | K893245 |
| Device Name: | L30-LB- INFANT LIMB BAND |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Contact | Paris Walker |
| Correspondent | Paris Walker CONTOUR ELECTRODES, INC. 100 S. 13TH ST. Herrin, IL 62948 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-28 |
| Decision Date | 1989-06-20 |