AUDICOR UPGRADE SYSTEM— 510(k) K032145
Substantially EquivalentInovise Medical, Inc.
FDA 510(k) clearance K032145 for AUDICOR UPGRADE SYSTEM, Substantially Equivalent on 2003-10-31. Applicant: Inovise Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Inovise Medical, Inc.
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newberg, OR, US
Recent devices under product code DPS
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 DPS
product code DPS- Death
- 7
- Total
- 7
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.