The following data is part of a premarket notification filed by Rnk Products with the FDA for Rnk Telephonic Stethoscope, Model Tr-1.
Device ID | K034046 |
510k Number | K034046 |
Device Name: | RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 |
Classification | Stethoscope, Electronic |
Applicant | RNK PRODUCTS 12700 DIAMOND DRIVE Burnsville, MN 55337 |
Contact | Charles R Abbruscato |
Correspondent | Charles R Abbruscato RNK PRODUCTS 12700 DIAMOND DRIVE Burnsville, MN 55337 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-29 |
Decision Date | 2004-03-10 |
Summary: | summary |