510(k) K232010
K232010 is an FDA 510(k) premarket notification submitted by Aion Biosystems, Inc. for the device "iTEMPSHIELD". The FDA issued a decision of Substantially Equivalent on August 4, 2023. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Aion Biosystems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2023
- Date Received
- July 6, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Continuous Measurement Thermometer
- Device Class
- Class II
- Regulation Number
- 880.2910
- Review Panel
- HO
- Submission Type
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.