AUDICOR SENSOR, MODELS: 2.0, 3.0— 510(k) K080602
Substantially EquivalentInovise Medical, Inc.
FDA 510(k) clearance K080602 for AUDICOR SENSOR, MODELS: 2.0, 3.0, Substantially Equivalent on 2008-09-25. Applicant: Inovise Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Inovise Medical, Inc.
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
Recent devices under product code DRX
view allMore clearances from Inovise Medical, Inc.
view all- K151433 — AUDICOR CA300/CC100 Analyzer with SDB
- K131883 — AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
- K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR)
- K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
- K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.