COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)— 510(k) K900910
Substantially EquivalentCobe Laboratories, Inc.
FDA 510(k) clearance K900910 for COBE AIR EMBOLI PROTECTION SYSTEM (AEPS), Substantially Equivalent on 1990-05-22. Applicant: Cobe Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Laboratories, Inc.
- Product code
- Code DTW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code DTW
view all- K150530 — Level Sensor, Level Sensor Tape
- K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM
- K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
- K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
- K910599 — CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR
More clearances from Cobe Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.