The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Tympanic Thermometer Mc-500.
| Device ID | K922344 |
| 510k Number | K922344 |
| Device Name: | OMRON TYMPANIC THERMOMETER MC-500 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Lee A Cabot |
| Correspondent | Lee A Cabot OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1993-06-29 |