AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)— 510(k) K110569
Substantially EquivalentInovise Medical, Inc.
FDA 510(k) clearance K110569 for AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR), Substantially Equivalent on 2011-10-24. Applicant: Inovise Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Inovise Medical, Inc.
- Product code
- Code MLO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaverton, OR, US
Recent devices under product code MLO
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)
- K103516 — AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.