ENVOY

Oximeter

MENNEN MEDICAL LTD.

The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Envoy.

Pre-market Notification Details

• Device ID: K022168
• 510k Number: K022168
• Device Name: ENVOY
• Classification: Oximeter
• Applicant: MENNEN MEDICAL LTD. 10123 MAIN ST. Clarence, NY 14031
• Contact: David P Johnson
• Correspondent: David P Johnson; MENNEN MEDICAL LTD. 10123 MAIN ST. Clarence, NY 14031
• Product Code: DQA
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-07-03
• Decision Date: 2002-08-01
• Summary: summary