The following data is part of a premarket notification filed by Rnk Products, Inc. with the FDA for Tr-usb Telephonic Stethoscope.
| Device ID | K081032 |
| 510k Number | K081032 |
| Device Name: | TR-USB TELEPHONIC 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 | 2008-04-11 |
| Decision Date | 2008-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850033167108 | K081032 | 000 |