The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Extended Measurements System.
| Device ID | K051450 |
| 510k Number | K051450 |
| Device Name: | EXTENDED MEASUREMENTS SYSTEM |
| Classification | Stethoscope, Electronic |
| Applicant | INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
| Contact | Steve C Hesler |
| Correspondent | Steve C Hesler INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-02 |
| Decision Date | 2005-11-10 |
| Summary: | summary |