The following data is part of a premarket notification filed by Protron Technologies, Llc with the FDA for Protron Technologies, Llc Stethotron.
| Device ID | K082771 |
| 510k Number | K082771 |
| Device Name: | PROTRON TECHNOLOGIES, LLC STETHOTRON |
| Classification | Stethoscope, Electronic |
| Applicant | PROTRON TECHNOLOGIES, LLC 141 OAKDENE AVE. Leonia, NJ 07605 |
| Contact | Leon M Dondysh |
| Correspondent | Leon M Dondysh PROTRON TECHNOLOGIES, LLC 141 OAKDENE AVE. Leonia, NJ 07605 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2009-02-27 |
| Summary: | summary |