The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Aerovent Ii Chc Collapsible Holding Chamber.
| Device ID | K012939 |
| 510k Number | K012939 |
| Device Name: | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 P.O. BOX 2805 Plattsburgh, NY 12901 |
| Contact | James A Cochie |
| Correspondent | James A Cochie MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 P.O. BOX 2805 Plattsburgh, NY 12901 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2001-09-28 |