The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Return Electrode Monitor.
| Device ID | K801153 |
| 510k Number | K801153 |
| Device Name: | VALLEYLAB RETURN ELECTRODE MONITOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-14 |
| Decision Date | 1980-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521033788 | K801153 | 000 |