The following data is part of a premarket notification filed by Thinklabs Inc. with the FDA for Rhythm Digital Electronic Stethoscope.
| Device ID | K032230 |
| 510k Number | K032230 |
| Device Name: | RHYTHM DIGITAL ELECTRONIC STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | THINKLABS INC. 30 NORTHPORT ROAD Sound Beach, NY 11789 |
| Contact | Richard Lanzillotto |
| Correspondent | Richard Lanzillotto THINKLABS INC. 30 NORTHPORT ROAD Sound Beach, NY 11789 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899529001106 | K032230 | 000 |