The following data is part of a premarket notification filed by Cher Mel Corp. with the FDA for Littman Type Sh-6010, Nurse Type.
Device ID | K842203 |
510k Number | K842203 |
Device Name: | LITTMAN TYPE SH-6010, NURSE TYPE |
Classification | Stethoscope, Manual |
Applicant | CHER MEL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDE |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-04 |
Decision Date | 1985-06-06 |