The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Monaghan Aerochamber With Mask.
Device ID | K874513 |
510k Number | K874513 |
Device Name: | MONAGHAN AEROCHAMBER WITH MASK |
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 | 1987-11-02 |
Decision Date | 1987-12-30 |