The following data is part of a premarket notification filed by Kinsa, Inc. with the FDA for Kinsa Quickcare Thermometer.
| Device ID | K173730 |
| 510k Number | K173730 |
| Device Name: | Kinsa QuickCare Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KINSA, Inc. 535 Mission St, 18th Floor San Francisco, CA 94105 |
| Contact | David Gal |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-12-06 |
| Decision Date | 2018-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850608006146 | K173730 | 000 |
| 00850608006122 | K173730 | 000 |
| 00850608006115 | K173730 | 000 |
| 00850608006108 | K173730 | 000 |
| 00850608006092 | K173730 | 000 |