SPINNAKER

Calculator, Pulmonary Function Data

CYBERMEDIC, INC.

The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Spinnaker.

Pre-market Notification Details

• Device ID: K861418
• 510k Number: K861418
• Device Name: SPINNAKER
• Classification: Calculator, Pulmonary Function Data
• Applicant: CYBERMEDIC, INC. P.O. BOX 3468 Boulder, CO 80307
• Contact: Curt Brown
• Correspondent: Curt Brown; CYBERMEDIC, INC. P.O. BOX 3468 Boulder, CO 80307
• Product Code: BZC
• CFR Regulation Number: 868.1880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-04-15
• Decision Date: 1986-05-09