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510(k) K874688

FLOWTRON AC200/2 by Huntleigh Technology, Inc. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1988
Date Received
November 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

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  • K900882 — MULTI DOPPLEX, MD-1 (August 22, 1990)
  • K900618 — HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 (April 25, 1990)
  • K890012 — HUNTLEIGH DYNAMIC FLOTATION SYSTEM (March 29, 1989)
  • K884451 — DOPCORD PPG (January 12, 1989)
  • K881632 — FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT (September 26, 1988)
  • K882644 — HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 (August 10, 1988)

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