The following data is part of a premarket notification filed by Rnk Products, Inc. with the FDA for Ppa/bt-rb Stethoscope.
| Device ID | K132405 |
| 510k Number | K132405 |
| Device Name: | PPA/BT-RB STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | RNK PRODUCTS, INC. 8247 Devereux Dr Ste 101 Melbourne, FL 32940 |
| Contact | Charles R Abbruscato |
| Correspondent | Charles R Abbruscato RNK PRODUCTS, INC. 8247 Devereux Dr Ste 101 Melbourne, FL 32940 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-02 |
| Decision Date | 2013-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677997001022 | K132405 | 000 |
| 00677996001016 | K132405 | 000 |
| 00677986001026 | K132405 | 000 |
| 00677986001019 | K132405 | 000 |