ASPIRE

Meter, Peak Flow, Spirometry

DURA PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Dura Pharmaceuticals, Inc. with the FDA for Aspire.

Pre-market Notification Details

• Device ID: K936110
• 510k Number: K936110
• Device Name: ASPIRE
• Classification: Meter, Peak Flow, Spirometry
• Applicant: DURA PHARMACEUTICALS, INC. 5880 PACIFIC CENTER BLVD. San Diego, CA 92121
• Contact: Kathleen Heffernan
• Correspondent: Kathleen Heffernan; DURA PHARMACEUTICALS, INC. 5880 PACIFIC CENTER BLVD. San Diego, CA 92121
• Product Code: BZH
• CFR Regulation Number: 868.1860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-23
• Decision Date: 1995-03-23