K962991 is an FDA 510(k) clearance for the BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER. This device is classified as a Continuous Measurement Thermometer (Class II - Special Controls, product code FLL).
Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on September 12, 1996, 42 days after receiving the submission on August 1, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2910. A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf..
| 510(k) Number | K962991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1996 |
| Decision Date | September 12, 1996 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLL — Continuous Measurement Thermometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2910 |
| Definition | A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf. |