The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Littmann Scope-to Scope Software System.
Device ID | K101834 |
510k Number | K101834 |
Device Name: | 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | 3M COMPANY 3M CENTER, BLDG. 275-05-W-06 St. Paul, MN 55144 -1000 |
Contact | Jizhong Jin |
Correspondent | Jizhong Jin 3M COMPANY 3M CENTER, BLDG. 275-05-W-06 St. Paul, MN 55144 -1000 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-01 |
Decision Date | 2010-09-03 |
Summary: | summary |