510(k) K212412
K212412 is an FDA 510(k) premarket notification submitted by Medicore Co., Ltd. for the device "IRIS-XP". The FDA issued a decision of Substantially Equivalent on September 13, 2021. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Medicore Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2021
- Date Received
- August 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type