The following data is part of a premarket notification filed by Rnk Products, Inc. with the FDA for Rnk Electronic Stethoscope.
Device ID | K072026 |
510k Number | K072026 |
Device Name: | RNK ELECTRONIC STETHOSCOPE |
Classification | Stethoscope, Electronic |
Applicant | RNK PRODUCTS, INC. 12700 DIAMOND DRIVE Burnsville, MN 55337 |
Contact | Charles R Abbruscato |
Correspondent | Charles R Abbruscato RNK PRODUCTS, INC. 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 | 2007-07-24 |
Decision Date | 2007-10-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00677992002000 | K072026 | 000 |
00677986002009 | K072026 | 000 |