FLEXLAB 3.6, ACCELERATOR A3600

Electrode, Ion Specific, Potassium

INPECO S.P.A.

The following data is part of a premarket notification filed by Inpeco S.p.a. with the FDA for Flexlab 3.6, Accelerator A3600.

Pre-market Notification Details

• Device ID: K121012
• 510k Number: K121012
• Device Name: FLEXLAB 3.6, ACCELERATOR A3600
• Classification: Electrode, Ion Specific, Potassium
• Applicant: INPECO S.P.A. 11 VIA G. DI VITTORIO Segrate, Milan, IT 20090
• Contact: Roberto Tamborra
• Correspondent: Roberto Tamborra; INPECO S.P.A. 11 VIA G. DI VITTORIO Segrate, Milan, IT 20090
• Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: JGS
• Subsequent Product Code: JJE
• Subsequent Product Code: JQP
• CFR Regulation Number: 862.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-03
• Decision Date: 2012-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
7640172342503	K121012	000
7640172341506	K121012	000
07640172340004	K121012	000
07640172342008	K121012	000
07640172341001	K121012	000
07640172344002	K121012	000