GAMBRO ADSORBA 150C— 510(k) K873643
Substantially EquivalentGambro, Inc.
FDA 510(k) clearance K873643 for GAMBRO ADSORBA 150C, Substantially Equivalent on 1987-12-29. Applicant: Gambro, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro, Inc.
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
Recent devices under product code FLD
view all- K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
- K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS)
- K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
- K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
- K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
More clearances from Gambro, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.