510(k) DEN230068
DEN230068 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190". The FDA issued a decision of De Novo Granted on May 21, 2024. The device falls under product code SBE (Digital Physical/Chemical Sterilization Process Sensor), a Class II device regulated under 21 CFR 880.2801. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 21, 2024
- Date Received
- September 29, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Physical/Chemical Sterilization Process Sensor
- Device Class
- Class II
- Regulation Number
- 880.2801
- Review Panel
- HO
- Submission Type
A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.