The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Electro Blue Ecg Elect. Foam, Silver/silver Chlo..
| Device ID | K894991 |
| 510k Number | K894991 |
| Device Name: | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. |
| Classification | Electrode, Electrocardiograph |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Lora Jones |
| Correspondent | Lora Jones LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-10-26 |