The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Mc-245, Mc-246, Mc-247, Mc-341, Mc-343, Mc-344.
| Device ID | K091676 |
| 510k Number | K091676 |
| Device Name: | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-09-01 |
| Summary: | summary |