510(k) DEN230068
- Device
- 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
- Applicant
- 3M Company
- 510(k) number
- DEN230068
- Product code
- SBE
- Decision
- Unknown (DENG)
- Decision date
- 2024-05-21
- Date received
- 2023-09-29
- Regulation
- 880.2801
- Classification name
- Digital Physical/Chemical Sterilization Process Sensor
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Michelle Larsen
- Address
- 3m Center 2510 Conway Ave., Bldg. 275-5w-06 St. Paul MN US 55144 55144
FDA Registration Numbers#
- 3007620861
- 3031841433
- 3009609218
- 3042272797
- 3031757047
Source Documents#
510(k) summary PDF not indicated by FDA