FAST-PATCH

Automated External Defibrillators (non-wearable)

PHYSIO-CONTROL CORP.

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

Pre-market Notification Details

• Device ID: K941970
• 510k Number: K941970
• Device Name: FAST-PATCH
• Classification: Automated External Defibrillators (non-wearable)
• 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: MKJ
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-22
• Decision Date: 1994-12-07