The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Pregelled Infant Disposable Ecg Electrode.
| Device ID | K862756 |
| 510k Number | K862756 |
| Device Name: | PREGELLED INFANT DISPOSABLE ECG ELECTRODE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Michael S Bartlett |
| Correspondent | Michael S Bartlett LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-08-06 |