510(k) clearances

3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190

3M Company · General Hospital

DEN230068UnknownDirectSBE
Open FDA's page for this record
Third party flag
N
City
St. Paul
Advisory committee description
General Hospital
Address 1
3m Center
Address 2
2510 Conway Ave., Bldg. 275-5w-06
Product code
SBE
Zip code
55144
Applicant
3M Company
Decision date
2024-05-21
Decision code
DENG
Country code
US
Device name
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
Advisory committee
HO
Contact
Michelle Larsen
K number
DEN230068
State
MN
Date received
2023-09-29
Review advisory committee
HO
Postal code
55144
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Digital Physical/Chemical Sterilization Process Sensor
Medical specialty description
General Hospital
Regulation number
880.2801
Device class
2
Registration number
3031841433, 3007620861, 3009609218, 3042272797, 3031757047
FEI number
3031841433, 3007620861, 3009609218, 3042272797, 3031757047
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.