The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Electrode Using Promeon Rg-60 Series Gel.
| Device ID | K915333 |
| 510k Number | K915333 |
| Device Name: | ELECTRODE USING PROMEON RG-60 SERIES GEL |
| 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 | 1991-11-26 |
| Decision Date | 1992-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003828 | K915333 | 000 |
| 00888912340748 | K915333 | 000 |
| 00888912335768 | K915333 | 000 |
| 00888912335751 | K915333 | 000 |
| 00888912335706 | K915333 | 000 |
| 00888912335690 | K915333 | 000 |
| 00888912335683 | K915333 | 000 |
| 00888912025102 | K915333 | 000 |
| 00888912023603 | K915333 | 000 |
| 00888912023597 | K915333 | 000 |
| 00888912023559 | K915333 | 000 |
| 00888912000239 | K915333 | 000 |
| 00888912340878 | K915333 | 000 |
| 00888912340885 | K915333 | 000 |
| 00888912340892 | K915333 | 000 |
| 90884521162927 | K915333 | 000 |
| 90884521162910 | K915333 | 000 |
| 90884521148136 | K915333 | 000 |
| 90884521148112 | K915333 | 000 |
| 10884521162914 | K915333 | 000 |
| 00888912023610 | K915333 | 000 |
| 00888912357272 | K915333 | 000 |
| 00888912357265 | K915333 | 000 |
| 00888912357074 | K915333 | 000 |
| 00888912340915 | K915333 | 000 |
| 00888912340908 | K915333 | 000 |
| 00888912000222 | K915333 | 000 |