The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Ring Electrode.
| Device ID | K933805 |
| 510k Number | K933805 |
| Device Name: | RING ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton M Cadwell |
| Correspondent | Carlton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-04 |
| Decision Date | 1994-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067101551 | K933805 | 000 |
| 00840067101117 | K933805 | 000 |
| 00840067100240 | K933805 | 000 |
| 00840067100233 | K933805 | 000 |