The following data is part of a premarket notification filed by 3m Company with the FDA for Littman Tunable Stethoscope 2136.
Device ID | K821909 |
510k Number | K821909 |
Device Name: | LITTMAN TUNABLE STETHOSCOPE 2136 |
Classification | Stethoscope, Manual |
Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
Product Code | LDE |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-28 |
Decision Date | 1982-07-14 |