The following data is part of a premarket notification filed by Tiba Medical, Inc. with the FDA for Ambulo 2400.
| Device ID | K080274 |
| 510k Number | K080274 |
| Device Name: | AMBULO 2400 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | TIBA MEDICAL, INC. 2701 N.W. VAUGHN ST. SUITE 470 Portland, OR 97210 |
| Contact | Merat Bagha |
| Correspondent | Merat Bagha TIBA MEDICAL, INC. 2701 N.W. VAUGHN ST. SUITE 470 Portland, OR 97210 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345023350 | K080274 | 000 |