The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Babe-ease Neonatal Cloth Ecg Electrode.
| Device ID | K896844 |
| 510k Number | K896844 |
| Device Name: | BABE-EASE NEONATAL CLOTH ECG ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Lora L Jones |
| Correspondent | Lora L Jones LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1990-02-12 |