The following data is part of a premarket notification filed by Kinsa, Inc. with the FDA for Kinsa Smart Thermometer.
| Device ID | K132514 |
| 510k Number | K132514 |
| Device Name: | KINSA SMART THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KINSA, INC. 603 GREENWICH ST. #101B New York, NY 10014 |
| Contact | Lael J Pickett |
| Correspondent | Lael J Pickett KINSA, INC. 603 GREENWICH ST. #101B New York, NY 10014 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-12-02 |
| Summary: | summary |