AEROCHAMBER

Mouthpiece, Breathing

MONAGHAN MEDICAL CORP.

The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Aerochamber.

Pre-market Notification Details

• Device ID: K872037
• 510k Number: K872037
• Device Name: AEROCHAMBER
• Classification: Mouthpiece, Breathing
• Applicant: MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901
• Contact: James A Cochie
• Correspondent: James A Cochie; MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901
• Product Code: BYP
• CFR Regulation Number: 868.5620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-05-27
• Decision Date: 1987-07-24