QUIK COMBO

Electrode, Electrocardiograph

PHYSIO-CONTROL CORP.

The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Quik Combo.

Pre-market Notification Details

• Device ID: K943301
• 510k Number: K943301
• Device Name: QUIK COMBO
• Classification: Electrode, Electrocardiograph
• Applicant: PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706
• Contact: Sherri L Pocock
• Correspondent: Sherri L Pocock; PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-08
• Decision Date: 1995-02-03