The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics Hg (hydrogel) Series Skin Temperature Sensor.
| Device ID | K933832 |
| 510k Number | K933832 |
| Device Name: | ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Harold Bryan |
| Correspondent | Harold Bryan ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-05 |
| Decision Date | 1994-01-28 |