MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER

Nebulizer, Medicinal, Non-ventilatory (atomizer)

MONAGHAN MEDICAL CORP.

The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Modified Aerochamber M.v. Aerosol Holding Chamber.

Pre-market Notification Details

• Device ID: K900557
• 510k Number: K900557
• Device Name: MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER
• Classification: Nebulizer, Medicinal, Non-ventilatory (atomizer)
• 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: CCQ
• CFR Regulation Number: 868.5640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-02-07
• Decision Date: 1991-04-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50604351985501	K900557	000
50604351985105	K900557	000
00762860000827	K900557	000