AEROSTAR

Apparatus, Gas-scavenging

BIOSAFETY SYSTEMS, INC.

The following data is part of a premarket notification filed by Biosafety Systems, Inc. with the FDA for Aerostar.

Pre-market Notification Details

• Device ID: K921313
• 510k Number: K921313
• Device Name: AEROSTAR
• Classification: Apparatus, Gas-scavenging
• Applicant: BIOSAFETY SYSTEMS, INC. 8380 CAMINO SANTA FE San Diego, CA 92121
• Product Code: CBN
• CFR Regulation Number: 868.5430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-18
• Decision Date: 1992-09-11