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510(k) K832355

CRASH CART by Quinton, Inc. — Product Code BZN

K832355 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "CRASH CART". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Quinton, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
July 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device Class
Class I
Regulation Number
868.6175
Review Panel
AN
Submission Type

Other clearances by Quinton, Inc.

  • K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (September 5, 2003)
  • K021906 — QUINTON Q-CATH, MODEL 000460 (September 4, 2002)
  • K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (January 25, 2001)
  • K001492 — QUINTON Q-STRESS, MODEL 000483 (August 9, 2000)
  • K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (March 6, 2000)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K971397 — VIEWCATH 3-D CATHETER PULLBACK (August 25, 1997)
  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER (September 13, 1996)

Other clearances for product code BZN

  • K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (November 25, 1992)
  • K872558 — CART, EMERGENCY, CARDIOPULMONARY (July 24, 1987)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K840264 — SERVO CART 170 (February 4, 1984)
  • K832697 — RMP INTUBATION EQUIP. STORAGE TRAY (December 27, 1983)
  • K832356 — PORTABLE OPERAT. RM. MONITORS HS30/40 (October 28, 1983)
  • K772320 — EMERGENCY CART (January 3, 1978)

FDA data resources