510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K950766Substantially Equivalent

Sigma 8000 and Sigma 8002

Sigma Intl. General Medical Apparatus, Inc., Medina NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950766 is the FDA 510(k) clearance record for SIGMA 8000 AND SIGMA 8002, a class II device, cleared for Sigma Intl. General Medical Apparatus, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list one 510(k) clearance for Sigma Intl. General Medical Apparatus, Inc. As of , FDA records show no recalls naming K950766.

Clearance record

Decision date
Received
(33 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Sigma Intl. General Medical Apparatus, Inc. 11020 W. Center St. Ext, Medina NY
510(k) summary
Summary
Third party review
No

Clearances, product code FRN

Trailing 12 months
2 clearances under product code FRN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260