SIGMA 7000

Pump, Infusion

SIGMA

The following data is part of a premarket notification filed by Sigma with the FDA for Sigma 7000.

Pre-market Notification Details

• Device ID: K820038
• 510k Number: K820038
• Device Name: SIGMA 7000
• Classification: Pump, Infusion
• Applicant: SIGMA MD
• Product Code: FRN
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-01-07
• Decision Date: 1983-01-26