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510(k) K013976

BOEHRINGER MRI SUCTION REGULATORY by Boehringer Laboratories — Product Code KDP

K013976 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "BOEHRINGER MRI SUCTION REGULATORY". The FDA issued a decision of Substantially Equivalent on January 8, 2002. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2002
Date Received
December 3, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Boehringer Laboratories

  • K243399 — Boehringer Laboratories Liver Retractor (July 2, 2025)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)
  • K234145 — ViSiGi 3D Gastric Sizing Tube (January 26, 2024)
  • K151990 — Tissue Removal System (September 11, 2015)
  • K150781 — Tissue Removal Pouch (June 19, 2015)
  • K130483 — BOEHRINGER GASTRIC SIZING TUBE (March 28, 2013)
  • K061788 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (July 11, 2006)
  • K060277 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (March 3, 2006)
  • K020538 — BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES (May 15, 2002)
  • K014187 — AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM (February 6, 2002)

Other clearances for product code KDP

  • K944479 — PM3300 INTERMITTENT VACUUM (December 22, 1994)
  • K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (July 21, 1994)
  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)
  • K843591 — INTERCEPT (October 19, 1984)

FDA data resources