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510(k) K863936

DUFFY BOLUS INJECTOR by Viox Corp. — Product Code IWR

K863936 is an FDA 510(k) premarket notification submitted by Viox Corp. for the device "DUFFY BOLUS INJECTOR". The FDA issued a decision of Substantially Equivalent on Jan 6, 1987. The device falls under product code IWR (Holder, Syringe, Lead), a Class I device regulated under 21 CFR 892.6500. Viox Corp. has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 6, 1987
Date Received
Oct 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Holder, Syringe, Lead
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type
510(k) Exempt

Other clearances by Viox Corp.

  • K872656 — LEAD GLASS SHIELDS (Jul 16, 1987)

Other clearances for product code IWR

  • K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (Feb 19, 1994)
  • K872656 — LEAD GLASS SHIELDS (Jul 16, 1987)
  • K811688 — TUNGSTEN SYRINGE SHIELD (Jul 2, 1981)

FDA data resources

Source: FDA 510(k) database entry for K863936. Report a data issue: hello@regdatalab.com.