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510(k) K071231

EDAC QUANTIFIER by Luna Innovations, Inc. — Product Code KRL

K071231 is an FDA 510(k) premarket notification submitted by Luna Innovations, Inc. for the device "EDAC QUANTIFIER". The FDA issued a decision of Substantially Equivalent on May 17, 2007. The device falls under product code KRL (Detector, Bubble, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4205.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2007
Date Received
May 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type

Other clearances for product code KRL

  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K090698 — CAPIOX BUBBLE TRAP WITH X-COATING (June 8, 2009)
  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
  • K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM (October 29, 1996)
  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K925541 — STOCKERT 1/4 BUBBLE SENSOR (February 2, 1993)
  • K911632 — CAPIOX(R) BUBBLE TRAP (July 9, 1991)
  • K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (February 3, 1987)

FDA data resources