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510(k) K933366

I.V. LINK by Deville Laboratories, Inc. — Product Code FPO

K933366 is an FDA 510(k) premarket notification submitted by Deville Laboratories, Inc. for the device "I.V. LINK". The FDA issued a decision of Substantially Equivalent on January 10, 1994. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1994
Date Received
July 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled
Device Class
Class II
Regulation Number
880.6910
Review Panel
HO
Submission Type

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  • K952447 — HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (November 22, 1995)
  • K946101 — EMERGENCY/ACCIDENT TROLLEY 550 (February 7, 1995)
  • K945431 — MODEL 792 CONVERGE, MODEL 793 VISION 2000 (January 25, 1995)
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FDA data resources