The following data is part of a premarket notification filed by Centauri Manufacturing, Inc. with the FDA for Dorches(tm) Lifesound(tm).
| Device ID | K870810 |
| 510k Number | K870810 |
| Device Name: | DORCHES(TM) LIFESOUND(TM) |
| Classification | Stethoscope, Electronic |
| Applicant | CENTAURI MANUFACTURING, INC. 4416 RUSSELL RD. Lynnwood, WA 98037 |
| Contact | John R Thompson |
| Correspondent | John R Thompson CENTAURI MANUFACTURING, INC. 4416 RUSSELL RD. Lynnwood, WA 98037 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-06-29 |