The following data is part of a premarket notification filed by Conphar, Inc. with the FDA for Conphar Delee Hillis Stethoscope.
Device ID | K813298 |
510k Number | K813298 |
Device Name: | CONPHAR DELEE HILLIS STETHOSCOPE |
Classification | Stethoscope, Fetal |
Applicant | CONPHAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HGN |
CFR Regulation Number | 884.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-23 |
Decision Date | 1981-12-08 |