ACAPELLA

Spirometer, Therapeutic (incentive)

DHD HEALTHCARE CORP.

The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Acapella.

Pre-market Notification Details

• Device ID: K002768
• 510k Number: K002768
• Device Name: ACAPELLA
• Classification: Spirometer, Therapeutic (incentive)
• Applicant: DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163
• Contact: Lawrence Weinstein
• Correspondent: Lawrence Weinstein; DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163
• Product Code: BWF
• CFR Regulation Number: 868.5690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-06
• Decision Date: 2000-12-05